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← Head and Neck Neoplasm

NCT00117572 · STUDY IN CONTEXT

Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Survival rates over 6 years.

Source null

→

secondary · POSTED

DFFS rates over 6 years. DFFS is time from randomization to distant recurrence or death from any cause

Source null

→

secondary · POSTED

Recurrence-free survival rates over 6 years. Recurrence-free survival is time from randomization to local, regional, or distant recurrence or death from any cause

Source null

→

secondary · POSTED

Percentage of patients with local/regional recurrence

Source null

→

secondary · POSTED

Percentage of patients with distant recurrence

Source null

→

secondary · POSTED

FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)

Survivors who completed the questionnaire. (Patients with missing data excluded.)

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Quality of Life (FACT H&N)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00117572
qol key
qol-0005
source section id
NCT00117572-om-0005
source outcome index
5
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Quality of Life (FACT H&N)
measure definition
FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)
time frame
Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Survivors who completed the questionnaire. (Patients with missing data excluded.)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Unnamed quality-of-life measure · Quality of Life (Normalcy of Diet)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00117572
qol key
qol-0006
source section id
NCT00117572-om-0006
source outcome index
6
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Quality of Life (Normalcy of Diet)
measure definition
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
time frame
Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Survivors who completed the questionnaire. (Patients with missing data excluded.)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Unnamed quality-of-life measure · Quality of Life (Speech)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00117572
qol key
qol-0007
source section id
NCT00117572-om-0007
source outcome index
7
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Quality of Life (Speech)
measure definition
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
time frame
Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Survivors who completed the questionnaire. (Patients with missing data excluded.)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Unnamed quality-of-life measure · Quality of Life (McMaster)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00117572
qol key
qol-0008
source section id
NCT00117572-om-0008
source outcome index
8
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Quality of Life (McMaster)
measure definition
McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)
time frame
Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Survivors who completed the questionnaire. (Patients with missing data excluded.)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Quality of Life (FACT H&N)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00117572
qol key
qol-0009
source section id
NCT00117572-om-0009
source outcome index
9
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Quality of Life (FACT H&N)
measure definition
FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)
time frame
Change from baseline to 1 year (1 year-pre)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Survivors who completed the questionnaire. (Patients with missing data excluded.)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Unnamed quality-of-life measure · Quality of Life (Normalcy of Diet)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00117572
qol key
qol-0010
source section id
NCT00117572-om-0010
source outcome index
10
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Quality of Life (Normalcy of Diet)
measure definition
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
time frame
Change from baseline to 1 year (1 year-pre)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Survivors who completed the questionnaire. (Patients with missing data excluded.)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Unnamed quality-of-life measure · Quality of Life (Speech)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00117572
qol key
qol-0011
source section id
NCT00117572-om-0011
source outcome index
11
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Quality of Life (Speech)
measure definition
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
time frame
Change from baseline to 1 year (1 year-pre)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Survivors who completed the questionnaire. (Patients with missing data excluded.)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Unnamed quality-of-life measure · Quality of Life (McMaster)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00117572
qol key
qol-0012
source section id
NCT00117572-om-0012
source outcome index
12
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Quality of Life (McMaster)
measure definition
McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)
time frame
Change from baseline to 1 year (1 year-pre)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Survivors who completed the questionnaire. (Patients with missing data excluded.)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT00117572
trial label
Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
2
qol Count
8
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    outcome key
    om-0000
    source section id
    NCT00117572-om-0000
    source outcome index
    0
    endpoint
    Overall Survival: Time From Randomization to Death From Any Cause
    endpoint definition
    Survival rates over 6 years.
    time origin
    Up to 6 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    outcome key
    om-0001
    source section id
    NCT00117572-om-0001
    source outcome index
    1
    endpoint
    Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause
    endpoint definition
    DFFS rates over 6 years. DFFS is time from randomization to distant recurrence or death from any cause
    time origin
    Up to 6 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    outcome key
    om-0002
    source section id
    NCT00117572-om-0002
    source outcome index
    2
    endpoint
    Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause
    endpoint definition
    Recurrence-free survival rates over 6 years. Recurrence-free survival is time from randomization to local, regional, or distant recurrence or death from any cause
    time origin
    Up to 6 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    outcome key
    om-0003
    source section id
    NCT00117572-om-0003
    source outcome index
    3
    endpoint
    Failure Pattern (Local/Regional Recurrence)
    endpoint definition
    Percentage of patients with local/regional recurrence
    time origin
    Up to 6 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    outcome key
    om-0004
    source section id
    NCT00117572-om-0004
    source outcome index
    4
    endpoint
    Failure Pattern (Distant Recurrence)
    endpoint definition
    Percentage of patients with distant recurrence
    time origin
    Up to 6 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    outcome key
    om-0005
    source section id
    NCT00117572-om-0005
    source outcome index
    5
    endpoint
    Quality of Life (FACT H&N)
    endpoint definition
    FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)
    time origin
    Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Survivors who completed the questionnaire. (Patients with missing data excluded.)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Induction Plus Chemoradiotherapy
    regimen
    Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks. Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) cisplatin: 75 mg/m2 on day 1 hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details
    analyzed count
    138
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00117572-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Chemoradiotherapy
    regimen
    Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details
    analyzed count
    135
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00117572-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Induction Plus Chemoradiotherapy
    regimen
    Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks. Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) cisplatin: 75 mg/m2 on day 1 hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details
    analyzed count
    138
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00117572-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Chemoradiotherapy
    regimen
    Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details
    analyzed count
    135
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00117572-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Induction Plus Chemoradiotherapy
    regimen
    Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks. Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) cisplatin: 75 mg/m2 on day 1 hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details
    analyzed count
    138
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00117572-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Chemoradiotherapy
    regimen
    Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details
    analyzed count
    135
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00117572-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Induction Plus Chemoradiotherapy
    regimen
    Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks. Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) cisplatin: 75 mg/m2 on day 1 hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details
    analyzed count
    138
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00117572-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Chemoradiotherapy
    regimen
    Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details
    analyzed count
    135
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00117572-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Induction Plus Chemoradiotherapy
    regimen
    Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks. Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) cisplatin: 75 mg/m2 on day 1 hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details
    analyzed count
    138
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00117572-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Chemoradiotherapy
    regimen
    Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details
    analyzed count
    135
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00117572-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Induction Plus Chemoradiotherapy
    regimen
    Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks. Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) cisplatin: 75 mg/m2 on day 1 hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details
    analyzed count
    77
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00117572-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Chemoradiotherapy
    regimen
    Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details
    analyzed count
    85
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00117572-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    harm key
    EG000
    source section id
    NCT00117572-ae
    event group key
    EG000
    event group label
    Induction Plus Chemoradiotherapy
    serious affected
    65
    serious at risk
    138
    other affected
    132
    other at risk
    138
    frequency threshold
    5
    collection period
    6 years
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    harm key
    EG001
    source section id
    NCT00117572-ae
    event group key
    EG001
    event group label
    Chemoradiotherapy
    serious affected
    38
    serious at risk
    135
    other affected
    129
    other at risk
    135
    frequency threshold
    5
    collection period
    6 years
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    qol key
    qol-0005
    source section id
    NCT00117572-om-0005
    source outcome index
    5
    instrument
    FACT
    instrument basis
    matched 'fact' in the study's own wording
    scale title
    Quality of Life (FACT H&N)
    measure definition
    FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)
    time frame
    Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Survivors who completed the questionnaire. (Patients with missing data excluded.)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    qol key
    qol-0006
    source section id
    NCT00117572-om-0006
    source outcome index
    6
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Quality of Life (Normalcy of Diet)
    measure definition
    Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
    time frame
    Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Survivors who completed the questionnaire. (Patients with missing data excluded.)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    qol key
    qol-0007
    source section id
    NCT00117572-om-0007
    source outcome index
    7
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Quality of Life (Speech)
    measure definition
    Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
    time frame
    Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Survivors who completed the questionnaire. (Patients with missing data excluded.)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    qol key
    qol-0008
    source section id
    NCT00117572-om-0008
    source outcome index
    8
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Quality of Life (McMaster)
    measure definition
    McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)
    time frame
    Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Survivors who completed the questionnaire. (Patients with missing data excluded.)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    qol key
    qol-0009
    source section id
    NCT00117572-om-0009
    source outcome index
    9
    instrument
    FACT
    instrument basis
    matched 'fact' in the study's own wording
    scale title
    Quality of Life (FACT H&N)
    measure definition
    FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)
    time frame
    Change from baseline to 1 year (1 year-pre)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Survivors who completed the questionnaire. (Patients with missing data excluded.)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    qol key
    qol-0010
    source section id
    NCT00117572-om-0010
    source outcome index
    10
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Quality of Life (Normalcy of Diet)
    measure definition
    Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
    time frame
    Change from baseline to 1 year (1 year-pre)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Survivors who completed the questionnaire. (Patients with missing data excluded.)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    qol key
    qol-0011
    source section id
    NCT00117572-om-0011
    source outcome index
    11
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Quality of Life (Speech)
    measure definition
    Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
    time frame
    Change from baseline to 1 year (1 year-pre)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Survivors who completed the questionnaire. (Patients with missing data excluded.)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-head-and-neck-neoplasm
    nct id
    NCT00117572
    qol key
    qol-0012
    source section id
    NCT00117572-om-0012
    source outcome index
    12
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Quality of Life (McMaster)
    measure definition
    McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)
    time frame
    Change from baseline to 1 year (1 year-pre)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Survivors who completed the questionnaire. (Patients with missing data excluded.)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice