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NCT01898494 · STUDY IN CONTEXT

Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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

Progression-free survival is defined as the time from randomization/assignment of post-surgical treatment to the appearance of lesions, including primary, nodal or new site, or death, whichever occurs first. These patients are considered disease-free after surgery so the appearance of any lesions is counted as progression. Kaplan-Meier estimate was used to characterize progression-free survival rate at 2 years.

Eligible and treated patients

→

primary · POSTED

Surgery quality was evaluated based on grade 3-4 bleeding events per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 during surgery and positive margins after surgery. Per CTCAE v5.0, grade 3 = severe and grade 4 = life-threatening. Having grade 3-4 bleeding or positive margins indicates worse outcomes.

Patients who received surgery

→

secondary · POSTED

Low Risk: T1-T2, N0-N1 AND clear (\> 3mm) margins, AND no extranodal extension (ENE) or PNI/LVI. Intermediate Risk: Any of the following features: one or more "close" (\< 3mm) margin(s), OR "Minimal" (\< 1mm) ENE, OR N2a (1 or more lymph node \>3cm in diameter), OR N2b (2-4 lymph nodes positive, any diameter \< 6cm), OR with perineural invastion or lymphovascular invasion. High Risk: Any of the following features: one or more positive margin(s) with any T stage, OR "Extensive" (\> 1mm) ENE, OR \> 5 metastatic lymph nodes (regardless of primary tumor margin status).

Patients who received surgery

→

secondary · POSTED

The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20-item written questionnaire. It evaluates the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. This instrument has been psychometrically validated in head and neck cancer patients. Two summary scores can be obtained from the MDADI: 1) global and 2) composite. The global scale is a single question, scored individually, to assess the overall impact that swallowing abilities have on quality of life ("my swallowing impacts my day-to-day life"). The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. This study reports the composite MDADI score. The summary MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning).

Eligible and treated patients with baseline MDADI scores available

→

secondary · POSTED

The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20-item written questionnaire. It evaluates the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. This instrument has been psychometrically validated in head and neck cancer patients. Two summary scores can be obtained from the MDADI: 1) global and 2) composite. The global scale is a single question, scored individually, to assess the overall impact that swallowing abilities have on quality of life ("my swallowing impacts my day-to-day life"). The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. This study reports the composite MDADI score. The summary MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning).

Eligible and treated patients with MDADI scores after surgery available

→

secondary · POSTED

The FACT-H\&N (version 4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. FACT-HN total score ranges between 0 and 148. The higher the score, the better the QOL.

Eligible and treated patients with FACT-HN total scores 6 months after treatment available

→

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

Unnamed quality-of-life measure · Swallowing Function Before Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI)

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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
nct id
NCT01898494
qol key
qol-0003
source section id
NCT01898494-om-0003
source outcome index
3
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Swallowing Function Before Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI)
measure definition
The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20-item written questionnaire. It evaluates the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. This instrument has been psychometrically validated in head and neck cancer patients. Two summary scores can be obtained from the MDADI: 1) global and 2) composite. The global scale is a single question, scored individually, to assess the overall impact that swallowing abilities have on quality of life ("my swallowing impacts my day-to-day life"). The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. This study reports the composite MDADI score. The summary MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning).
time frame
Assessed at baseline
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Eligible and treated patients with baseline MDADI scores available
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 · Swallowing Function After Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI)

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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
nct id
NCT01898494
qol key
qol-0004
source section id
NCT01898494-om-0004
source outcome index
4
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Swallowing Function After Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI)
measure definition
The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20-item written questionnaire. It evaluates the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. This instrument has been psychometrically validated in head and neck cancer patients. Two summary scores can be obtained from the MDADI: 1) global and 2) composite. The global scale is a single question, scored individually, to assess the overall impact that swallowing abilities have on quality of life ("my swallowing impacts my day-to-day life"). The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. This study reports the composite MDADI score. The summary MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning).
time frame
Assessed 4-6 weeks after surgery
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Eligible and treated patients with MDADI scores after surgery available
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 (QOL) at 6 Months After Treatment Assessed by Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-HN) Total Score

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
nct id
NCT01898494
qol key
qol-0005
source section id
NCT01898494-om-0005
source outcome index
5
instrument
FACT
instrument basis
matched 'fact-hn' in the study's own wording
scale title
Quality of Life (QOL) at 6 Months After Treatment Assessed by Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-HN) Total Score
measure definition
The FACT-H\&N (version 4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. FACT-HN total score ranges between 0 and 148. The higher the score, the better the QOL.
time frame
Assessed at 6 months after treatment
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher the score, the better
population note
Eligible and treated patients with FACT-HN total scores 6 months after treatment available
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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
nct id
NCT01898494
trial label
Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer
applicability
unclear
applicability note
Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
5
qol Count
3
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    outcome key
    om-0000
    source section id
    NCT01898494-om-0000
    source outcome index
    0
    endpoint
    Progression-free Survival Rate at 2 Years
    endpoint definition
    Progression-free survival is defined as the time from randomization/assignment of post-surgical treatment to the appearance of lesions, including primary, nodal or new site, or death, whichever occurs first. These patients are considered disease-free after surgery so the appearance of any lesions is counted as progression. Kaplan-Meier estimate was used to characterize progression-free survival rate at 2 years.
    time origin
    Assessed every 3 months for 2 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and treated patients
    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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    outcome key
    om-0001
    source section id
    NCT01898494-om-0001
    source outcome index
    1
    endpoint
    Proportion of Patients With Grade III or IV Oropharyngeal Bleeding or Positive Margins
    endpoint definition
    Surgery quality was evaluated based on grade 3-4 bleeding events per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 during surgery and positive margins after surgery. Per CTCAE v5.0, grade 3 = severe and grade 4 = life-threatening. Having grade 3-4 bleeding or positive margins indicates worse outcomes.
    time origin
    Assessed during surgery and directly after surgery
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who received surgery
    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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    outcome key
    om-0002
    source section id
    NCT01898494-om-0002
    source outcome index
    2
    endpoint
    Distribution of Histologic Risk Status
    endpoint definition
    Low Risk: T1-T2, N0-N1 AND clear (\> 3mm) margins, AND no extranodal extension (ENE) or PNI/LVI. Intermediate Risk: Any of the following features: one or more "close" (\< 3mm) margin(s), OR "Minimal" (\< 1mm) ENE, OR N2a (1 or more lymph node \>3cm in diameter), OR N2b (2-4 lymph nodes positive, any diameter \< 6cm), OR with perineural invastion or lymphovascular invasion. High Risk: Any of the following features: one or more positive margin(s) with any T stage, OR "Extensive" (\> 1mm) ENE, OR \> 5 metastatic lymph nodes (regardless of primary tumor margin status).
    time origin
    Assessed after directly surgery
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who received surgery
    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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    outcome key
    om-0003
    source section id
    NCT01898494-om-0003
    source outcome index
    3
    endpoint
    Swallowing Function Before Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI)
    endpoint definition
    The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20-item written questionnaire. It evaluates the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. This instrument has been psychometrically validated in head and neck cancer patients. Two summary scores can be obtained from the MDADI: 1) global and 2) composite. The global scale is a single question, scored individually, to assess the overall impact that swallowing abilities have on quality of life ("my swallowing impacts my day-to-day life"). The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. This study reports the composite MDADI score. The summary MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning).
    time origin
    Assessed at baseline
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and treated patients with baseline MDADI scores available
    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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    outcome key
    om-0004
    source section id
    NCT01898494-om-0004
    source outcome index
    4
    endpoint
    Swallowing Function After Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI)
    endpoint definition
    The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20-item written questionnaire. It evaluates the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. This instrument has been psychometrically validated in head and neck cancer patients. Two summary scores can be obtained from the MDADI: 1) global and 2) composite. The global scale is a single question, scored individually, to assess the overall impact that swallowing abilities have on quality of life ("my swallowing impacts my day-to-day life"). The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. This study reports the composite MDADI score. The summary MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning).
    time origin
    Assessed 4-6 weeks after surgery
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and treated patients with MDADI scores after surgery available
    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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    outcome key
    om-0005
    source section id
    NCT01898494-om-0005
    source outcome index
    5
    endpoint
    Quality of Life (QOL) at 6 Months After Treatment Assessed by Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-HN) Total Score
    endpoint definition
    The FACT-H\&N (version 4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. FACT-HN total score ranges between 0 and 148. The higher the score, the better the QOL.
    time origin
    Assessed at 6 months after treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and treated patients with FACT-HN total scores 6 months after treatment available
    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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm S (Surgery) Then Arm A (Low Risk, Observation)
    regimen
    Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation.
    analyzed count
    38
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01898494-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)
    regimen
    Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks.
    analyzed count
    100
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01898494-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)
    regimen
    Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks.
    analyzed count
    108
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01898494-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)
    regimen
    Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
    analyzed count
    113
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01898494-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm S (Surgery)
    regimen
    Patients undergo transoral surgical resection of the oropharyngeal tumor.
    analyzed count
    495
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01898494-om-0001#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm S (Surgery)
    regimen
    Patients undergo transoral surgical resection of the oropharyngeal tumor.
    analyzed count
    359
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01898494-om-0002#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm S (Surgery) Then Arm A (Low Risk, Observation)
    regimen
    Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation.
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01898494-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)
    regimen
    Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks.
    analyzed count
    91
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01898494-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    outcome key
    om-0003
    arm key
    OG002
    arm label
    Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)
    regimen
    Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks.
    analyzed count
    99
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01898494-om-0003#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    outcome key
    om-0003
    arm key
    OG003
    arm label
    Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)
    regimen
    Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
    analyzed count
    102
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01898494-om-0003#groups/OG003
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Arm S (Surgery) Then Arm A (Low Risk, Observation)
    regimen
    Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation.
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01898494-om-0004#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)
    regimen
    Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks.
    analyzed count
    83
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01898494-om-0004#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    harm key
    EG000
    source section id
    NCT01898494-ae
    event group key
    EG000
    event group label
    Arm S (Transoral Surgery)
    serious affected
    85
    serious at risk
    495
    other affected
    110
    other at risk
    495
    frequency threshold
    5
    collection period
    Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
    event definition
    Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
    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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    harm key
    EG001
    source section id
    NCT01898494-ae
    event group key
    EG001
    event group label
    Arm A (Observation)
    serious affected
    0
    serious at risk
    49
    other affected
    1
    other at risk
    49
    frequency threshold
    5
    collection period
    Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
    event definition
    Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
    undenominated 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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    harm key
    EG002
    source section id
    NCT01898494-ae
    event group key
    EG002
    event group label
    Arm B (Radiotherapy IMRT 50 Gy)
    serious affected
    17
    serious at risk
    120
    other affected
    57
    other at risk
    120
    frequency threshold
    5
    collection period
    Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
    event definition
    Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
    undenominated 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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    harm key
    EG003
    source section id
    NCT01898494-ae
    event group key
    EG003
    event group label
    Arm C (Radiotherapy IMRT 60 Gy)
    serious affected
    31
    serious at risk
    127
    other affected
    71
    other at risk
    127
    frequency threshold
    5
    collection period
    Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
    event definition
    Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
    undenominated 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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    harm key
    EG004
    source section id
    NCT01898494-ae
    event group key
    EG004
    event group label
    Arm D (Cisplatin + IMRT 66 Gy)
    serious affected
    81
    serious at risk
    134
    other affected
    96
    other at risk
    134
    frequency threshold
    5
    collection period
    Assessed weekly during the 7 weeks of treatment, then every 2 months up to 2 years post-registration, then every 6 months up to 3 years post-registration
    event definition
    Serious adverse events are defined as grade 3 or higher adverse events that are possibly, probably, or definitely related to protocol therapy. Other adverse events are defined as grade 1 or grade 2 adverse events that are possibly, probably, or definitely related to protocol therapy with a frequency of at least 5% in a given arm. All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
    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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    qol key
    qol-0003
    source section id
    NCT01898494-om-0003
    source outcome index
    3
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Swallowing Function Before Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI)
    measure definition
    The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20-item written questionnaire. It evaluates the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. This instrument has been psychometrically validated in head and neck cancer patients. Two summary scores can be obtained from the MDADI: 1) global and 2) composite. The global scale is a single question, scored individually, to assess the overall impact that swallowing abilities have on quality of life ("my swallowing impacts my day-to-day life"). The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. This study reports the composite MDADI score. The summary MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning).
    time frame
    Assessed at baseline
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Eligible and treated patients with baseline MDADI scores available
    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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    qol key
    qol-0004
    source section id
    NCT01898494-om-0004
    source outcome index
    4
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Swallowing Function After Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI)
    measure definition
    The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20-item written questionnaire. It evaluates the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. This instrument has been psychometrically validated in head and neck cancer patients. Two summary scores can be obtained from the MDADI: 1) global and 2) composite. The global scale is a single question, scored individually, to assess the overall impact that swallowing abilities have on quality of life ("my swallowing impacts my day-to-day life"). The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. This study reports the composite MDADI score. The summary MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning).
    time frame
    Assessed 4-6 weeks after surgery
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Eligible and treated patients with MDADI scores after surgery available
    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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT01898494
    qol key
    qol-0005
    source section id
    NCT01898494-om-0005
    source outcome index
    5
    instrument
    FACT
    instrument basis
    matched 'fact-hn' in the study's own wording
    scale title
    Quality of Life (QOL) at 6 Months After Treatment Assessed by Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-HN) Total Score
    measure definition
    The FACT-H\&N (version 4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. FACT-HN total score ranges between 0 and 148. The higher the score, the better the QOL.
    time frame
    Assessed at 6 months after treatment
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher the score, the better
    population note
    Eligible and treated patients with FACT-HN total scores 6 months after treatment available
    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