Trial · NCT02254278
Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal Cancer
NCT02254278, Phase 2, Completed, NRG Oncology; results first posted 2020-08-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal Cancer. Trials, record NCT02254278. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02254278
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal Cancer
- NCT number
- NCT02254278
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 316 participants, actual
- Lead sponsor
- NRG Oncology
- Conditions
Stage III Oropharyngeal Squamous Cell Carcinoma, Stage IVA Oropharyngeal Squamous Cell Carcinoma, Stage IVB Oropharyngeal Squamous Cell Carcinoma, Stage IVC Oropharyngeal Squamous Cell Carcinoma, Tongue Carcinoma
- Interventions
- Cisplatin, IMRT 6 weeks, IMRT 5 weeks
- First posted
- 2014-10-01
- Last updated
- 2026-05-22
- Results first posted
- 2020-08-12
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival) | From randomization to 2 years | Progression is defined as local, regional, or distant disease progression or death due to any cause. Percentage is estimated using the binomial distribution. |
| Secondary | Percentage of Participants With Local-regional Failure | From randomization to 2 years | 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. |
| Secondary | Percentage of Participants With Distant Metastasis | From randomization to 2 years | 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. |
| Secondary | Percentage of Participants Alive | from randomization to 2 years | 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. |
| Secondary | Percentage of Participants With Grade 3+ Adverse Events | 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 | 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. |
| Secondary | Mean One-year Total MD Anderson Dysphagia Inventory (MDADI) Score (Patient-reported Swallowing Outcome) | One year post-RT. Radiation therapy (RT) ends at approximately 6 weeks for Arm 1 and 5 weeks for Arm 2 | 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. |
| Secondary | Negative Predictive Value (NPV) of Post-treatment FDG-PET/CT Scan [Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT)] for Progression-free Survival and Local-regional Control at Two Years | 3 months (scan) and two years after the end of RT (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2) | NPV is the percentage of participants alive and failure-free at 2 years among those with a negative post-treatment scan, as evaluated by central review. Negative scan determined as follows: primary site, right neck, left neck evaluated using a 5-point ordinal scale: 1-Definite complete metabolic response (CMR), 2-Likely CMR, 3-Likely inflammatory, 4-Likely residual metabolic disease (RMD), and 5-Definite RMD. 'Negative'= 1 or 2, 'Indeterminate'=3, 'Positive' = 4 or 5. 'Negative' for all three evaluation sites = overall score of 'Negative.' Progression (failure) is defined as local, regional, or distant disease progression (PR) or any death. Local-regional progression (failure) is defined as local or regional PR, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks post RT, death due to study cancer or unknown causes without documented PR. The protocol specified that both arms would be combined for analysis. |
| Secondary | Percentage of Participants Positive for Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) After Treatment (Detection Rate) | Between 2 weeks to 1 month after treatment completion (approximately 6 weeks). | Positive HPV DNA status is defined as 5 or more HPV DNA fragments per mL of blood plasma, assessed by tumor-tissue modified viral (TTMV) testing. |
| Secondary | Change in Number of HPV DNA Fragments/mL (Copy Number) From Baseline to During Treatment (HPV DNA Rate Decline) | Baseline and during treatment (obtained after 20 Gy of radiotherapy and before 28 Gy, approximately between day 10 and 14) | Calculated as treatment value - baseline value. HPV DNA was assessed by tumor-tissue modified viral (TTMV) testing. |
| Secondary | Correlation of Baseline Log HPV DNA Copy Number and Gross Tumor Volume (GTV) | Baseline | HPV DNA copy number is the number of HPV DNA fragments per mL of blood plasma, assessed by tumor-tissue modified viral (TTMV) testing. The natural logarithm of HPV DNA copy is used to determine correlation. GTV is the volume of the tumor determined by imaging used for treatment planning. The summary data of these two measures are reported separately in corresponding outcome measures. Correlation is measured by the Pearson correlation coefficient and ranges from -1 to +1, where ±1 indicates the strongest possible (negative or positive) correlation and 0 indicates no correlation. The study protocol indicates that participants are analyzed as a single group, treatment arms combined. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival) | From randomization to 2 years | Two-year data was available for 147/157 (Arm 1) and 145/149 (Arm 2) randomized and eligible participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Local-regional Failure | From randomization to 2 years | Randomized and eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Distant Metastasis | From randomization to 2 years | Randomized and eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Alive | from randomization to 2 years | Randomized and eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Grade 3+ Adverse Events | 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 | Randomized and eligible participants who started study treatment. Adverse event data was not available for all participants at each time point. | percentage of participants | NUMBER |
| SECONDARY | Mean One-year Total MD Anderson Dysphagia Inventory (MDADI) Score (Patient-reported Swallowing Outcome) | One year post-RT. Radiation therapy (RT) ends at approximately 6 weeks for Arm 1 and 5 weeks for Arm 2 | 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. | score on a scale | MEAN |
| SECONDARY | Negative Predictive Value (NPV) of Post-treatment FDG-PET/CT Scan [Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT)] for Progression-free Survival and Local-regional Control at Two Years | 3 months (scan) and two years after the end of RT (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2) | Randomized and eligible participants with negative post-treatment PET | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Positive for Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) After Treatment (Detection Rate) | Between 2 weeks to 1 month after treatment completion (approximately 6 weeks). | Eligible participants with post-treatment HPV DNA value | percentage of participants | NUMBER |
| SECONDARY | Change in Number of HPV DNA Fragments/mL (Copy Number) From Baseline to During Treatment (HPV DNA Rate Decline) | Baseline and during treatment (obtained after 20 Gy of radiotherapy and before 28 Gy, approximately between day 10 and 14) | Eligible patients with baseline and during treatment HPV DNA values. | fragments/mL | MEAN |
| SECONDARY | Correlation of Baseline Log HPV DNA Copy Number and Gross Tumor Volume (GTV) | Baseline | Eligible participants with baseline HPV DNA value | correlation coefficient | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group43
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival) | IMRT 6 Weeks + Cisplatin (Arm 1) | 90.5 | 90% Confidence Interval 86.6 to NA | percentage of participants | |
| Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival) | IMRT 5 Weeks (Arm 2) | 87.6 | 90% Confidence Interval 83.3 to NA | percentage of participants | |
| Percentage of Participants With Local-regional Failure | IMRT 6 Weeks + Cisplatin | Six months | 0.7 | 95% Confidence Interval 0.1 to 3.3 | percentage of participants |
| Percentage of Participants With Local-regional Failure | IMRT 5 Weeks | Six months | 2.0 | 95% Confidence Interval 0.6 to 5.4 | percentage of participants |
| Percentage of Participants With Local-regional Failure | IMRT 6 Weeks + Cisplatin | Two years | 3.3 | 95% Confidence Interval 1.2 to 7.1 | percentage of participants |
| Percentage of Participants With Local-regional Failure | IMRT 5 Weeks | Two years | 9.5 | 95% Confidence Interval 5.5 to 15.0 | percentage of participants |
| Percentage of Participants With Distant Metastasis | IMRT 6 Weeks + Cisplatin | Six months | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Percentage of Participants With Distant Metastasis | IMRT 5 Weeks | Six months | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Percentage of Participants With Distant Metastasis | IMRT 6 Weeks + Cisplatin | Two years | 4.0 | 95% Confidence Interval 1.6 to 8.0 | percentage of participants |
| Percentage of Participants With Distant Metastasis | IMRT 5 Weeks | Two years | 2.1 | 95% Confidence Interval 0.6 to 5.5 | percentage of participants |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IMRT 6 Weeks + Cisplatin | 158 | |
| Overall Study | STARTED | IMRT 5 Weeks | 150 | |
| Overall Study | Eligible | IMRT 6 Weeks + Cisplatin | 157 | |
| Overall Study | Eligible | IMRT 5 Weeks | 149 | |
| Overall Study | Started Study Treatment | IMRT 6 Weeks + Cisplatin | 152 | |
| Overall Study | Started Study Treatment | IMRT 5 Weeks | 147 | |
| Overall Study | Negative Post-treatment PET | IMRT 6 Weeks + Cisplatin | 58 | |
| Overall Study | Negative Post-treatment PET | IMRT 5 Weeks | 57 | |
| Overall Study | COMPLETED | IMRT 6 Weeks + Cisplatin | 157 | |
| Overall Study | COMPLETED | IMRT 5 Weeks | 149 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events214
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | IMRT 6 Weeks + Cisplatin | 92 | 152 | |
| other | Anemia | Blood and lymphatic system disorders | IMRT 5 Weeks | 35 | 147 | |
| other | Ear pain | Ear and labyrinth disorders | IMRT 6 Weeks + Cisplatin | 8 | 152 | |
| other | Ear pain | Ear and labyrinth disorders | IMRT 5 Weeks | 4 | 147 | |
| other | Hearing impaired | Ear and labyrinth disorders | IMRT 6 Weeks + Cisplatin | 43 | 152 | |
| other | Hearing impaired | Ear and labyrinth disorders | IMRT 5 Weeks | 34 | 147 | |
| other | Tinnitus | Ear and labyrinth disorders | IMRT 6 Weeks + Cisplatin | 65 | 152 | |
| other | Tinnitus | Ear and labyrinth disorders | IMRT 5 Weeks | 41 | 147 | |
| other | Hypothyroidism | Endocrine disorders | IMRT 6 Weeks + Cisplatin | 18 | 152 | |
| other | Hypothyroidism | Endocrine disorders | IMRT 5 Weeks | 16 | 147 |
1 to 10 of 214Source ClinicalTrials.gov
See all 214 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IMRT 6 Weeks + Cisplatin | 6 | 152 |
| Total, all-cause mortality | IMRT 5 Weeks | 6 | 147 |
| Total, other adverse events | IMRT 6 Weeks + Cisplatin | 152 | 152 |
| Total, other adverse events | IMRT 5 Weeks | 147 | 147 |
| Total, serious adverse events | IMRT 6 Weeks + Cisplatin | 31 | 152 |
| Total, serious adverse events | IMRT 5 Weeks | 11 | 147 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33507809 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IMRT 6 Weeks + Cisplatin vs IMRT 5 Weeks: deaths from any cause | Trial comparisons |
| IMRT 6 Weeks + Cisplatin vs IMRT 5 Weeks: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02254278
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