Trial · NCT01706939
The Quarterback Trial: Reduced Dose Radiotherapy for HPV+ Oropharynx Cancer
NCT01706939, Phase 3, Active not recruiting, Icahn School of Medicine at Mount Sinai; results first posted 2022-09-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Quarterback Trial: Reduced Dose Radiotherapy for HPV+ Oropharynx Cancer. Trials, record NCT01706939. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01706939
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Quarterback Trial: Reduced Dose Radiotherapy for HPV+ Oropharynx Cancer
- NCT number
- NCT01706939
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 23 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Squamous Cell Carcinomas
- Interventions
- Reduced Dose Radiation, Standard Dose Radiation, Carboplatin
- First posted
- 2012-10-15
- Last updated
- 2026-04-09
- Results first posted
- 2022-09-01
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Progression Free Survival (PFS) | at 3 and 5 years | Progression free survival (PFS) at 5 years in patients with advanced HPV related oropharynx cancer, nasopharynx cancer or unknown primary treated with reduced or standard dose radiation. |
| Secondary | Number of Participants With Local-regional Control | at 3 years | Local-regional control (LRC) at 3 years in patients with advanced HPV related oropharynx cancer or unknown primary treated with reduced or standard dose radiation. |
| Secondary | Number of Participants With Overall Survival at 5 Years | at 5 years | Overall Survival (OS) 5 years treated with reduced or standard dose CRT. |
| Secondary | Number of Participants With Acute Toxicity of Chemoradiotherapy (CRT) | at 5 years | Number of participants with acute toxicity treated with reduced or standard dose CRT. |
| Secondary | Biomarkers Predictive of Failure | at 5 years | To determine biomarkers predictive of failure with either reduced or standard dose radiotherapy. |
| Secondary | Overall Survival at 15 Years | at 15 years | |
| Secondary | Change in MD Anderson Dysphagia Inventory (MDADI) From Baseline | Baseline and 5 years | MDADI is a questionnaire of 20 questions and contains a global subscale, and three other categories of questions (emotional, functional, and physical). The scores are summed and a mean score is calculated. This mean score was multiplied by 20 to obtain a score, with a range of 0 (extremely low functioning) to 100 (high functioning). Thus, a higher MDADI score represented better day-to-day functioning and better QOL. |
| Secondary | Change in MD Anderson Symptom Inventory Symptom Inventory and Severity (MDASI-HN SI and SS) | Baseline and 5 years | MD Anderson Symptom Inventory Symptom Inventory and Severity (MDASI-HN SI and SS) MDASI Head and Neck is a site-specific MDASI module which includes the core MDASI 13 symptom severity items (SS) and 6 symptom interference items (SI), alongside 9 items relevant to head and neck cancer. The scores are summed and a mean score is calculated on a scale of 0 (low severity or interference) to 10 (high severity or complete interference). In order to calculate the mean score, a majority of the subscale's items must have been completed. A lower or negative score reflects a better quality of life compared to baseline. |
| Secondary | Change in Xerostomia Questionnaire (XQ) | Baseline and 5 years | XQ is a nine questions survey developed specifically for xerostomia symptoms. The scores are summed and a mean score is calculated on a scale of 0 (low xerostomia interference) to 10 (high xerostomia interference). A lower or negative score reflects a better quality of life compared to baseline. |
| Secondary | Change in European Organization for Research and Treatment of Cancer Questionnaire for Head and Neck (EORTC HN) | Baseline and 5 years | The EORTC Head and Neck module was specifically designed and validated for head and neck cancer patients. This 35-item questionnaire contains 7 symptom scales (pain, swallowing, senses, speech, social eating, social contact, and sexuality), 6 single-item scales (difficulties of teeth, mouth opening, dry mouth, sticky saliva, coughing, and feeling ill), and 5 items about the additional use of pain medicine, nutritional supplements, and feeding tube and changes in body weight. All items were transformed to scales from 0 to 100, and divided into respective sub-scores of global health (GHS), functional (FS), and symptom scale (SS). Subscales from 0-100. A high score on global health and functional scale represents a better level of functioning, whereas a high score on a symptom scale and head and neck module indicates more severe symptoms. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Progression Free Survival (PFS) | at 3 and 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Local-regional Control | at 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Overall Survival at 5 Years | at 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Acute Toxicity of Chemoradiotherapy (CRT) | at 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Biomarkers Predictive of Failure | at 5 years | biomarkers | NUMBER | |
| SECONDARY | Overall Survival at 15 Years | at 15 years | |||
| SECONDARY | Change in MD Anderson Dysphagia Inventory (MDADI) From Baseline | Baseline and 5 years | Of the 20 participants, 3 had progression of disease, and 2 were excluded due to insufficient survey compliance. | score on a scale | MEAN |
| SECONDARY | Change in MD Anderson Symptom Inventory Symptom Inventory and Severity (MDASI-HN SI and SS) | Baseline and 5 years | Of the 20 participants, 3 had progression of disease, and 2 were excluded due to insufficient survey compliance. | score on a scale | MEAN |
| SECONDARY | Change in Xerostomia Questionnaire (XQ) | Baseline and 5 years | Of the 20 participants, 3 had progression of disease, and 2 were excluded due to insufficient survey compliance. | score on a scale | MEAN |
| SECONDARY | Change in European Organization for Research and Treatment of Cancer Questionnaire for Head and Neck (EORTC HN) | Baseline and 5 years | Of the 20 participants, 3 had progression of disease, and 2 were excluded due to insufficient survey compliance. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Progression Free Survival (PFS) | Reduced Dose Radiation | at 3 years | 10 | Participants | |
| Number of Participants With Progression Free Survival (PFS) | Standard Dose Radiation | at 3 years | 7 | Participants | |
| Number of Participants With Progression Free Survival (PFS) | Reduced Dose Radiation | at 5 years | 10 | Participants | |
| Number of Participants With Progression Free Survival (PFS) | Standard Dose Radiation | at 5 years | 7 | Participants | |
| Number of Participants With Local-regional Control | Reduced Dose Radiation | 10 | Participants | ||
| Number of Participants With Local-regional Control | Standard Dose Radiation | 7 | Participants | ||
| Number of Participants With Overall Survival at 5 Years | Reduced Dose Radiation | 10 | Participants | ||
| Number of Participants With Overall Survival at 5 Years | Standard Dose Radiation | 7 | Participants | ||
| Number of Participants With Acute Toxicity of Chemoradiotherapy (CRT) | Reduced Dose Radiation | 3 | Participants | ||
| Number of Participants With Acute Toxicity of Chemoradiotherapy (CRT) | Standard Dose Radiation | 1 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre Randomization | STARTED | Pre-Randomization | 23 | |
| Pre Randomization | STARTED | Reduced Dose Radiation | 0 | |
| Pre Randomization | STARTED | Standard Dose Radiation | 0 | |
| Pre Randomization | COMPLETED | Pre-Randomization | 20 | |
| Pre Randomization | COMPLETED | Reduced Dose Radiation | 0 | |
| Pre Randomization | COMPLETED | Standard Dose Radiation | 0 | |
| Pre Randomization | NOT COMPLETED | Pre-Randomization | 3 | |
| Pre Randomization | NOT COMPLETED | Reduced Dose Radiation | 0 | |
| Pre Randomization | NOT COMPLETED | Standard Dose Radiation | 0 | |
| Randomization | STARTED | Pre-Randomization | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events39
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 | Mucositis | Gastrointestinal disorders | Pre-Randomization | 0 | ||
| other | Mucositis | Gastrointestinal disorders | Reduced Dose Radiation | 1 | 12 | |
| other | Mucositis | Gastrointestinal disorders | Standard Dose Radiation | 1 | 8 | |
| other | Neutropenic fever | Infections and infestations | Pre-Randomization | 0 | ||
| other | Neutropenic fever | Infections and infestations | Reduced Dose Radiation | 0 | 12 | |
| other | Neutropenic fever | Infections and infestations | Standard Dose Radiation | 1 | 8 | |
| other | Urinary retention | Renal and urinary disorders | Pre-Randomization | 0 | ||
| other | Urinary retention | Renal and urinary disorders | Reduced Dose Radiation | 1 | 12 | |
| other | Urinary retention | Renal and urinary disorders | Standard Dose Radiation | 0 | 8 | |
| other | Acute hearing loss | Ear and labyrinth disorders | Pre-Randomization | 0 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pre-Randomization | 0 | 0 |
| Total, all-cause mortality | Reduced Dose Radiation | 2 | 12 |
| Total, all-cause mortality | Standard Dose Radiation | 1 | 8 |
| Total, other adverse events | Pre-Randomization | 0 | 0 |
| Total, other adverse events | Reduced Dose Radiation | 9 | 12 |
| Total, other adverse events | Standard Dose Radiation | 8 | 8 |
| Total, serious adverse events | Pre-Randomization | 0 | 0 |
| Total, serious adverse events | Reduced Dose Radiation | 2 | 12 |
| Total, serious adverse events | Standard Dose Radiation | 2 | 8 |
Source ClinicalTrials.gov
Papers35
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Reduced Dose Radiation vs Standard Dose Radiation: Number of Participants With Acute Toxicity of Chemoradiotherapy (CRT) | Trial comparisons |
| Reduced Dose Radiation vs Standard Dose Radiation: Number of Participants With Local-regional Control | Trial comparisons |
| Reduced Dose Radiation vs Standard Dose Radiation: Number of Participants With Overall Survival at 5 Years | 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/NCT01706939
GET https://conductscience.org/api/trials/v1/NCT01706939/results?page=2