Trial · NCT01898494
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
NCT01898494, Phase 2, Active not recruiting, ECOG-ACRIN Cancer Research Group; results first posted 2022-09-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT01898494. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01898494
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT01898494
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 519 participants, actual
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Conditions
- Human Papilloma Virus Infection, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVB Squamous Cell Carcinoma of the Oropharynx
- Interventions
- Transoral surgery, intensity-modulated radiation therapy, cisplatin, carboplatin
- First posted
- 2013-07-12
- Last updated
- 2026-04-01
- Results first posted
- 2022-09-28
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival Rate at 2 Years | Assessed every 3 months for 2 years | 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. |
| Primary | Proportion of Patients With Grade III or IV Oropharyngeal Bleeding or Positive Margins | Assessed during surgery and directly after surgery | 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. |
| Secondary | Distribution of Histologic Risk Status | Assessed after directly surgery | 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). |
| Secondary | Swallowing Function Before Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI) | Assessed at baseline | 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). |
| Secondary | Swallowing Function After Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI) | Assessed 4-6 weeks after surgery | 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). |
| Secondary | Quality of Life (QOL) at 6 Months After Treatment Assessed by Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-HN) Total Score | Assessed at 6 months after treatment | 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. |
| Other | Association Between TP53 Mutation and Progression-free Survival | Assessed every 3 months for 2 years, then every 6 months, up to 5 years | Progression-free survival is defined as the time from registration to the appearance of new metastatic lesions or objective tumor progression or death, whichever occurs first. Kaplan-Meier estimate was used to characterize progression-free survival. |
| Other | Association Between Radiation Resistance Markers and Progression-free Survival | Assessed every 3 months for 2 year, then every 6 months, up to 5 years | Progression-free survival is defined as the time from registration to the appearance of new metastatic lesions or objective tumor progression or death, whichever occurs first. Kaplan-Meier estimate was used to characterize progression-free survival. |
| Other | Usefulness of Biomarkers in Predicting Progression-free Survival | Assessed every 3 months for 2 years, then every 6 months, up to 5 years | Progression-free survival is defined as the time from registration to the appearance of new metastatic lesions or objective tumor progression or death, whichever occurs first. Kaplan-Meier estimate was used to characterize progression-free survival. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival Rate at 2 Years | Assessed every 3 months for 2 years | Eligible and treated patients | proportion of participants | NUMBER |
| PRIMARY | Proportion of Patients With Grade III or IV Oropharyngeal Bleeding or Positive Margins | Assessed during surgery and directly after surgery | Patients who received surgery | proportion of participants | NUMBER |
| SECONDARY | Distribution of Histologic Risk Status | Assessed after directly surgery | Patients who received surgery | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Swallowing Function Before Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI) | Assessed at baseline | Eligible and treated patients with baseline MDADI scores available | score on a scale | MEAN |
| SECONDARY | Swallowing Function After Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI) | Assessed 4-6 weeks after surgery | Eligible and treated patients with MDADI scores after surgery available | score on a scale | MEAN |
| SECONDARY | Quality of Life (QOL) at 6 Months After Treatment Assessed by Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-HN) Total Score | Assessed at 6 months after treatment | Eligible and treated patients with FACT-HN total scores 6 months after treatment available | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Association Between TP53 Mutation and Progression-free Survival | Assessed every 3 months for 2 years, then every 6 months, up to 5 years | |||
| OTHER_PRE_SPECIFIED | Association Between Radiation Resistance Markers and Progression-free Survival | Assessed every 3 months for 2 year, then every 6 months, up to 5 years | |||
| OTHER_PRE_SPECIFIED | Usefulness of Biomarkers in Predicting Progression-free Survival | Assessed every 3 months for 2 years, then every 6 months, up to 5 years |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival Rate at 2 Years | Arm S (Surgery) Then Arm A (Low Risk, Observation) | 0.969 | 90% Confidence Interval 0.919 to 1.00 | proportion of participants | |
| Progression-free Survival Rate at 2 Years | Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT) | 0.949 | 90% Confidence Interval 0.913 to 0.986 | proportion of participants | |
| Progression-free Survival Rate at 2 Years | Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT) | 0.96 | 90% Confidence Interval 0.928 to 0.993 | proportion of participants | |
| Progression-free Survival Rate at 2 Years | Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy) | 0.907 | 90% Confidence Interval 0.862 to 0.954 | proportion of participants | |
| Proportion of Patients With Grade III or IV Oropharyngeal Bleeding or Positive Margins | Arm S (Surgery) | 0.091 | 90% Confidence Interval 0.071 to 0.115 | proportion of participants | |
| Distribution of Histologic Risk Status | Arm S (Surgery) | Low Risk | 38 | Participants | |
| Distribution of Histologic Risk Status | Arm S (Surgery) | Intermediate Risk | 208 | Participants | |
| Distribution of Histologic Risk Status | Arm S (Surgery) | High Risk | 113 | Participants | |
| Swallowing Function Before Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI) | Arm S (Surgery) Then Arm A (Low Risk, Observation) | 89.1 | 95% Confidence Interval 84.7 to 93.5 | score on a scale | |
| Swallowing Function Before Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI) | Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT) | 90.2 | 95% Confidence Interval 87.8 to 92.5 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow55
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Step 1 (Arm S - Transoral Surgery) | STARTED | Arm S (Transoral Surgery) Then Arm A (Observation) | 49 | |
| Step 1 (Arm S - Transoral Surgery) | STARTED | Arm S (Transoral Surgery) Then Arm B (Radiotherapy IMRT 50 Gy) | 126 | |
| Step 1 (Arm S - Transoral Surgery) | STARTED | Arm S (Transoral Surgery) Then Arm C (Radiotherapy IMRT 60 Gy) | 132 | |
| Step 1 (Arm S - Transoral Surgery) | STARTED | Arm S (Transoral Surgery) Then Arm D (Chemo + IMRT 66 Gy) | 138 | |
| Step 1 (Arm S - Transoral Surgery) | STARTED | Not Being Assigned to Step 2 Adjuvant Treatment Arms | 74 | |
| Step 1 (Arm S - Transoral Surgery) | COMPLETED | Arm S (Transoral Surgery) Then Arm A (Observation) | 49 | |
| Step 1 (Arm S - Transoral Surgery) | COMPLETED | Arm S (Transoral Surgery) Then Arm B (Radiotherapy IMRT 50 Gy) | 126 | |
| Step 1 (Arm S - Transoral Surgery) | COMPLETED | Arm S (Transoral Surgery) Then Arm C (Radiotherapy IMRT 60 Gy) | 132 | |
| Step 1 (Arm S - Transoral Surgery) | COMPLETED | Arm S (Transoral Surgery) Then Arm D (Chemo + IMRT 66 Gy) | 138 | |
| Step 1 (Arm S - Transoral Surgery) | COMPLETED | Not Being Assigned to Step 2 Adjuvant Treatment Arms | 50 |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 participant flowAdverse events515
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 | Arm S (Transoral Surgery) | 0 | 495 | |
| other | Anemia | Blood and lymphatic system disorders | Arm A (Observation) | 0 | 49 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Radiotherapy IMRT 50 Gy) | 0 | 120 | |
| other | Anemia | Blood and lymphatic system disorders | Arm C (Radiotherapy IMRT 60 Gy) | 1 | 127 | |
| other | Anemia | Blood and lymphatic system disorders | Arm D (Cisplatin + IMRT 66 Gy) | 9 | 134 | |
| other | Fatigue | General disorders | Arm S (Transoral Surgery) | 0 | 495 | |
| other | Fatigue | General disorders | Arm A (Observation) | 0 | 49 | |
| other | Fatigue | General disorders | Arm B (Radiotherapy IMRT 50 Gy) | 3 | 120 | |
| other | Fatigue | General disorders | Arm C (Radiotherapy IMRT 60 Gy) | 17 | 127 | |
| other | Fatigue | General disorders | Arm D (Cisplatin + IMRT 66 Gy) | 31 | 134 |
1 to 10 of 515Source ClinicalTrials.gov
See all 515 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm S (Transoral Surgery) | 24 | 519 |
| Total, all-cause mortality | Arm A (Observation) | 1 | 49 |
| Total, all-cause mortality | Arm B (Radiotherapy IMRT 50 Gy) | 4 | 126 |
| Total, all-cause mortality | Arm C (Radiotherapy IMRT 60 Gy) | 7 | 132 |
| Total, all-cause mortality | Arm D (Cisplatin + IMRT 66 Gy) | 9 | 138 |
| Total, other adverse events | Arm S (Transoral Surgery) | 110 | 495 |
| Total, other adverse events | Arm A (Observation) | 1 | 49 |
| Total, other adverse events | Arm B (Radiotherapy IMRT 50 Gy) | 57 | 120 |
| Total, other adverse events | Arm C (Radiotherapy IMRT 60 Gy) | 71 | 127 |
| Total, other adverse events | Arm D (Cisplatin + IMRT 66 Gy) | 96 | 134 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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
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