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NCT02254278 · STUDY IN CONTEXT

Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced 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 is defined as local, regional, or distant disease progression or death due to any cause. Percentage is estimated using the binomial distribution.

Two-year data was available for 147/157 (Arm 1) and 145/149 (Arm 2) randomized and eligible participants.

→

secondary · POSTED

Local-regional failure is defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression. Distant metastasis and death due to other causes are considered competing risks. Local-regional failure time is defined as time from randomization to the date of first progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method.

Randomized and eligible participants

→

secondary · POSTED

Distant metastasis is defined as distant progression. Local-regional failure and death due to any cause are considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method.

Randomized and eligible participants

→

secondary · POSTED

Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.

Randomized and eligible participants

→

secondary · POSTED

Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.

Randomized and eligible participants who started study treatment. Adverse event data was not available for all participants at each time point.

→

secondary · POSTED

The MDADI is a 20-item tool with each item scored as Strongly agree; Agree; No opinion; Disagree; or Strongly disagree. There is 1 global item (G1), 6 emotional subscale items (E2-E7), 5 functional subscale items (F1-F5), and 8 physical subscale items (P1-P8). For all items except E7 and F2, Strongly agree corresponds to a score of 1, Agree 2, No opinion 3, Disagree 4, and Strongly disagree 5. For E7 and F2, the scores are reversed; these 2 items are rescored to match the others before calculating summary scores. The composite (total) score is the mean of the 19 items (other than G1) X 20. Composite scores range from 20 to 100 with higher scores indicating less dysphagia.

Randomized and eligible participants. Questionnaires were not completed by all participants. 121 Arm 1 and 106 Arm 2 participants had one year post-RT data.

→

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

Patient-reported symptom or function measure · Mean One-year Total MD Anderson Dysphagia Inventory (MDADI) Score (Patient-reported Swallowing Outcome)

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
NCT02254278
qol key
qol-0005
source section id
NCT02254278-om-0005
source outcome index
5
instrument
Patient-reported symptom or function measure
instrument basis
matched 'patient-reported' in the study's own wording
scale title
Mean One-year Total MD Anderson Dysphagia Inventory (MDADI) Score (Patient-reported Swallowing Outcome)
measure definition
The MDADI is a 20-item tool with each item scored as Strongly agree; Agree; No opinion; Disagree; or Strongly disagree. There is 1 global item (G1), 6 emotional subscale items (E2-E7), 5 functional subscale items (F1-F5), and 8 physical subscale items (P1-P8). For all items except E7 and F2, Strongly agree corresponds to a score of 1, Agree 2, No opinion 3, Disagree 4, and Strongly disagree 5. For E7 and F2, the scores are reversed; these 2 items are rescored to match the others before calculating summary scores. The composite (total) score is the mean of the 19 items (other than G1) X 20. Composite scores range from 20 to 100 with higher scores indicating less dysphagia.
time frame
One year post-RT. Radiation therapy (RT) ends at approximately 6 weeks for Arm 1 and 5 weeks for Arm 2
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Randomized and eligible participants. Questionnaires were not completed by all participants. 121 Arm 1 and 106 Arm 2 participants had one year post-RT data.
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
NCT02254278
trial label
Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced 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
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02254278
    outcome key
    om-0000
    source section id
    NCT02254278-om-0000
    source outcome index
    0
    endpoint
    Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival)
    endpoint definition
    Progression is defined as local, regional, or distant disease progression or death due to any cause. Percentage is estimated using the binomial distribution.
    time origin
    From randomization to 2 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Two-year data was available for 147/157 (Arm 1) and 145/149 (Arm 2) randomized and eligible participants.
    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
    NCT02254278
    outcome key
    om-0001
    source section id
    NCT02254278-om-0001
    source outcome index
    1
    endpoint
    Percentage of Participants With Local-regional Failure
    endpoint definition
    Local-regional failure is defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression. Distant metastasis and death due to other causes are considered competing risks. Local-regional failure time is defined as time from randomization to the date of first progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method.
    time origin
    From randomization to 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Randomized and eligible participants
    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
    NCT02254278
    outcome key
    om-0002
    source section id
    NCT02254278-om-0002
    source outcome index
    2
    endpoint
    Percentage of Participants With Distant Metastasis
    endpoint definition
    Distant metastasis is defined as distant progression. Local-regional failure and death due to any cause are considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method.
    time origin
    From randomization to 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Randomized and eligible participants
    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
    NCT02254278
    outcome key
    om-0003
    source section id
    NCT02254278-om-0003
    source outcome index
    3
    endpoint
    Percentage of Participants Alive
    endpoint definition
    Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.
    time origin
    from randomization to 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Randomized and eligible participants
    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
    NCT02254278
    outcome key
    om-0004
    source section id
    NCT02254278-om-0004
    source outcome index
    4
    endpoint
    Percentage of Participants With Grade 3+ Adverse Events
    endpoint definition
    Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.
    time origin
    End of radiation therapy (RT) (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2), then 1 month, 6 months, 1 year, and two years after end of RT
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Randomized and eligible participants who started study treatment. Adverse event data was not available for all participants at each time point.
    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
    NCT02254278
    outcome key
    om-0005
    source section id
    NCT02254278-om-0005
    source outcome index
    5
    endpoint
    Mean One-year Total MD Anderson Dysphagia Inventory (MDADI) Score (Patient-reported Swallowing Outcome)
    endpoint definition
    The MDADI is a 20-item tool with each item scored as Strongly agree; Agree; No opinion; Disagree; or Strongly disagree. There is 1 global item (G1), 6 emotional subscale items (E2-E7), 5 functional subscale items (F1-F5), and 8 physical subscale items (P1-P8). For all items except E7 and F2, Strongly agree corresponds to a score of 1, Agree 2, No opinion 3, Disagree 4, and Strongly disagree 5. For E7 and F2, the scores are reversed; these 2 items are rescored to match the others before calculating summary scores. The composite (total) score is the mean of the 19 items (other than G1) X 20. Composite scores range from 20 to 100 with higher scores indicating less dysphagia.
    time origin
    One year post-RT. Radiation therapy (RT) ends at approximately 6 weeks for Arm 1 and 5 weeks for Arm 2
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Randomized and eligible participants. Questionnaires were not completed by all participants. 121 Arm 1 and 106 Arm 2 participants had one year post-RT data.
    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
    NCT02254278
    outcome key
    om-0000
    arm key
    OG000
    arm label
    IMRT 6 Weeks + Cisplatin (Arm 1)
    regimen
    Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    analyzed count
    147
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02254278-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02254278
    outcome key
    om-0000
    arm key
    OG001
    arm label
    IMRT 5 Weeks (Arm 2)
    regimen
    IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    analyzed count
    145
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02254278-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02254278
    outcome key
    om-0001
    arm key
    OG000
    arm label
    IMRT 6 Weeks + Cisplatin
    regimen
    Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    analyzed count
    157
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02254278-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02254278
    outcome key
    om-0001
    arm key
    OG001
    arm label
    IMRT 5 Weeks
    regimen
    IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    analyzed count
    149
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02254278-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02254278
    outcome key
    om-0002
    arm key
    OG000
    arm label
    IMRT 6 Weeks + Cisplatin
    regimen
    Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    analyzed count
    157
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02254278-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02254278
    outcome key
    om-0002
    arm key
    OG001
    arm label
    IMRT 5 Weeks
    regimen
    IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    analyzed count
    149
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02254278-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02254278
    outcome key
    om-0003
    arm key
    OG000
    arm label
    IMRT 6 Weeks + Cisplatin
    regimen
    Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    analyzed count
    157
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02254278-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02254278
    outcome key
    om-0003
    arm key
    OG001
    arm label
    IMRT 5 Weeks
    regimen
    IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    analyzed count
    149
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02254278-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02254278
    outcome key
    om-0004
    arm key
    OG000
    arm label
    IMRT 6 Weeks + Cisplatin (Arm 1)
    regimen
    Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    analyzed count
    152
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02254278-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02254278
    outcome key
    om-0004
    arm key
    OG001
    arm label
    IMRT 5 Weeks (Arm 2)
    regimen
    IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    analyzed count
    147
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02254278-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02254278
    outcome key
    om-0005
    arm key
    OG000
    arm label
    IMRT 6 Weeks + Cisplatin (Arm 1)
    regimen
    Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    analyzed count
    121
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02254278-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02254278
    outcome key
    om-0005
    arm key
    OG001
    arm label
    IMRT 5 Weeks (Arm 2)
    regimen
    IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    analyzed count
    106
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02254278-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02254278
    harm key
    EG000
    source section id
    NCT02254278-ae
    event group key
    EG000
    event group label
    IMRT 6 Weeks + Cisplatin
    serious affected
    31
    serious at risk
    152
    other affected
    152
    other at risk
    152
    frequency threshold
    5
    collection period
    Weekly during treatment, at 1 and 3 months after end of treatment, then every 3 months from end of treatment for 2 years, every 6 months from end of treatment for 3 years, then annually until study completion. Maximum follow-up at time of reporting was 4.1 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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02254278
    harm key
    EG001
    source section id
    NCT02254278-ae
    event group key
    EG001
    event group label
    IMRT 5 Weeks
    serious affected
    11
    serious at risk
    147
    other affected
    147
    other at risk
    147
    frequency threshold
    5
    collection period
    Weekly during treatment, at 1 and 3 months after end of treatment, then every 3 months from end of treatment for 2 years, every 6 months from end of treatment for 3 years, then annually until study completion. Maximum follow-up at time of reporting was 4.1 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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02254278
    qol key
    qol-0005
    source section id
    NCT02254278-om-0005
    source outcome index
    5
    instrument
    Patient-reported symptom or function measure
    instrument basis
    matched 'patient-reported' in the study's own wording
    scale title
    Mean One-year Total MD Anderson Dysphagia Inventory (MDADI) Score (Patient-reported Swallowing Outcome)
    measure definition
    The MDADI is a 20-item tool with each item scored as Strongly agree; Agree; No opinion; Disagree; or Strongly disagree. There is 1 global item (G1), 6 emotional subscale items (E2-E7), 5 functional subscale items (F1-F5), and 8 physical subscale items (P1-P8). For all items except E7 and F2, Strongly agree corresponds to a score of 1, Agree 2, No opinion 3, Disagree 4, and Strongly disagree 5. For E7 and F2, the scores are reversed; these 2 items are rescored to match the others before calculating summary scores. The composite (total) score is the mean of the 19 items (other than G1) X 20. Composite scores range from 20 to 100 with higher scores indicating less dysphagia.
    time frame
    One year post-RT. Radiation therapy (RT) ends at approximately 6 weeks for Arm 1 and 5 weeks for Arm 2
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Randomized and eligible participants. Questionnaires were not completed by all participants. 121 Arm 1 and 106 Arm 2 participants had one year post-RT data.
    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