Trial · NCT01932697
Radiation Therapy and Docetaxel in Treating Patients With HPV-Related Oropharyngeal Cancer
NCT01932697, Phase 2, Completed, Mayo Clinic; results first posted 2019-09-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Radiation Therapy and Docetaxel in Treating Patients With HPV-Related Oropharyngeal Cancer. Trials, record NCT01932697. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01932697
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy and Docetaxel in Treating Patients With HPV-Related Oropharyngeal Cancer
- NCT number
- NCT01932697
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 81 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
Human Papillomavirus Infection, Stage I Oropharyngeal Squamous Cell Carcinoma, Stage II Oropharyngeal Squamous Cell Carcinoma, Stage III Oropharyngeal Squamous Cell Carcinoma, Stage IVA Oropharyngeal Squamous Cell Carcinoma, Stage IVB Oropharyngeal Squamous Cell Carcinoma
- Interventions
- Docetaxel, Hyperfractionation, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Quality-of-Life Assessment
- First posted
- 2013-08-30
- Last updated
- 2026-02-10
- Results first posted
- 2019-09-18
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 2-year Loco-regional Tumor Control (LRC) Rate | 2 years | The 2-year loco-regional tumor control (LRC) rate (percentage) is defined as the percentage of patients with no local/regional recurrence or death 2 years after study registration. |
| Secondary | Incidence of Grade 3 or Higher Mucositis Oral | 4 months post-hyperfractionated radiation therapy | The overall percentage of patients experiencing grade 3 or higher mucositis oral graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 are reported below. |
| Secondary | 2-year Overall Survival (OS) Rate | 2 years | The distribution of OS will be estimated using the method of Kaplan-Meier. |
| Secondary | 2-year Progression-free Survival (PFS) | From registration to the first of either disease recurrence or death, assessed up to 2 years | The distribution of PFS will be estimated using the method of Kaplan-Meier. |
| Secondary | 2-year Distant Metastasis-free Survival Rate | 2 years | The 2-year Distant metastasis-free survival rate (percentage) is defined as the percentage of patients with no distant recurrence or death 2 years after study registration. |
| Secondary | Change From Mean Baseline Score to Mean Score at 12 Months Post-RT in Swallow Function as Measured by the Pharyngeal Total Modified Barium Swallow Impairment Profile. | 12 months | The swallow evaluation consists of a modified barium swallow study(MBS), Functional Oral Intake Scale(FOIS), and Performance Status Scale Head \& Neck(PSS-HN).The 17 swallow questions are rated using a 0 to 5 point scale, with 0 meaning no impairment and 5 max impairment. 6 questions produce a total oral score; scores from 10 questions produce a total pharyngeal score; 1 question produces an esophageal score.The PAS is a validated 8-point scale that ranks the depth of the bolus entry into the airway.A score of 1 indicates no airway entrance;score of 6+ indicate bolus passage past the vocal folds (aspiration).FOIS ranges from 1(nothing by mouth) to 7(total oral diet with no restrictions).PSS-H\&N has 3 components:eating in public(0=always eat alone to 100=no restriction), understandability of speech(0=never understandable, score 100=always understandable), and normalcy of diet(score 0=tube fed to 100=full diet).These scores are summed and normalized to a 0 to 100 scale where 100 is best. |
| Secondary | Functional Assessment of Cancer Therapy Head and Neck (FACT H& N) (Version 4) | 1 year | The FACT-H\&N is a multidimensional, self-report QOL instrument specifically designed for use with head and neck cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, in addition to 12 site specific items to assess for head and neck related symptoms. Each item is rated on a 0 to 4 type scale where 4 is favorable and 0 unfavorable, and then combined to produce subscale scores for each domain, as well as a global QOL score- with possible score range from 0 to 156. Higher scores represent better QOL. |
| Secondary | European Organization for Research and Treatment for Cancer QOL Questionnaire for Head and Neck Cancer Module 35 (EORTC-QLQ HN35) | 1 year post-treatment | QOL was measured by the European Organization for Research and Treatment for Cancer QOL Questionnaire for Head and Neck Cancer Module 35 (EORTC-QLQ HN35) at baseline and at 1-year post-treatment. Each question scores 0-4, with 0 being favorable and 4 being unfavorable. The average total score at baseline and average total score at 12 months post-RT is reported. The max total score possible is 140(Unfavorable) and the minimum total score possible is 0(Favorable). An increase in score indicates a greater quality of life A paired t-test compares the scores at these two timepoints. |
| Secondary | EuroQol Five-dimensional Instrument (EQ-5D-3L) | 1 year post-treatment | QOL was measured by the three-level version of the EuroQol five-dimensional instrument (EQ-5D-3L) at baseline and 1-year post-treatment. This consisted of 5 questions, each score 0 to 3 points with 3 being unfavorable and 0 being favorable. The total possible score per patient per time point is 15 and a minimum score of 0(favorable). The change in average total score at baseline and 12 months post-RT is reported. A paired t-test compares the scores at these two time points. A higher score indicates greater impairment. |
| Other | Changes in Transforming Growth Factor (TGF)-beta1 Levels | Baseline to 1 week post-radiation | These markers will be correlated with clinical endpoints like acute adverse events, cumulative incidence rates of local/regional failure, overall survival, and disease-free survival. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 2-year Loco-regional Tumor Control (LRC) Rate | 2 years | percentage of patients | NUMBER | |
| SECONDARY | Incidence of Grade 3 or Higher Mucositis Oral | 4 months post-hyperfractionated radiation therapy | percentage of patients | NUMBER | |
| SECONDARY | 2-year Overall Survival (OS) Rate | 2 years | percentage of patients | NUMBER | |
| SECONDARY | 2-year Progression-free Survival (PFS) | From registration to the first of either disease recurrence or death, assessed up to 2 years | percentage of patients | NUMBER | |
| SECONDARY | 2-year Distant Metastasis-free Survival Rate | 2 years | percentage of patients | NUMBER | |
| SECONDARY | Change From Mean Baseline Score to Mean Score at 12 Months Post-RT in Swallow Function as Measured by the Pharyngeal Total Modified Barium Swallow Impairment Profile. | 12 months | All patients that completed a Swallow Function assessment at baseline and 12-month post-RT were included. The difference in dose (30 vs 36 Gy) was not expected to have any appreciable difference in toxicity or PRO. What they represented were two different risk groups, hence the need to publish separate cohort disease control metric and why it makes less sense to sort out risk groups for radiation toxicity. It was pre-specified to report this analysis to compare timepoints and not cohorts. | score on a scale | MEAN |
| SECONDARY | Functional Assessment of Cancer Therapy Head and Neck (FACT H& N) (Version 4) | 1 year | All patients treated per protocol and completed the FACT H\&N forms were included in this analysis. The difference in dose (30 vs 36 Gy) was not expected to have any appreciable difference in toxicity or PRO. What they represented were two different risk groups, hence the need to publish separate cohort disease control metric and why it makes less sense to sort out risk groups for radiation toxicity. It was pre-specified to report this analysis to compare timepoints and not cohorts. | score on a scale | MEAN |
| SECONDARY | European Organization for Research and Treatment for Cancer QOL Questionnaire for Head and Neck Cancer Module 35 (EORTC-QLQ HN35) | 1 year post-treatment | All patients treated per protocol and completed the EORTC-QLQ HN35 forms were included in this analysis. | score on a scale | MEAN |
| SECONDARY | EuroQol Five-dimensional Instrument (EQ-5D-3L) | 1 year post-treatment | All patients who were treated per protocol and who completed a EQ-5D-3L were included in this analysis. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Changes in Transforming Growth Factor (TGF)-beta1 Levels | Baseline to 1 week post-radiation |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 2-year Loco-regional Tumor Control (LRC) Rate | Cohort A (Intermediate Risk) | 100 | percentage of patients | ||
| 2-year Loco-regional Tumor Control (LRC) Rate | Cohort B (Extranodal Extension) | 93 | percentage of patients | ||
| 2-year Loco-regional Tumor Control (LRC) Rate | Overall (Cohort A + Cohort B) | 96.2 | percentage of patients | ||
| Incidence of Grade 3 or Higher Mucositis Oral | Cohort A (Intermediate Risk) | 8.3 | percentage of patients | ||
| Incidence of Grade 3 or Higher Mucositis Oral | Cohort B (Extranodal Extension) | 4.7 | percentage of patients | ||
| 2-year Overall Survival (OS) Rate | Cohort A | 100 | percentage of patients | ||
| 2-year Overall Survival (OS) Rate | Cohort B | 97.7 | percentage of patients | ||
| 2-year Progression-free Survival (PFS) | Cohort A (Intermediate Risk) | 97.2 | percentage of patients | ||
| 2-year Progression-free Survival (PFS) | Cohort B (Extranodal Extension) | 86.0 | percentage of patients | ||
| 2-year Distant Metastasis-free Survival Rate | Cohort A (Intermediate Risk) | 97.2 | percentage of patients |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A (Intermediate Risk) | 38 | |
| Overall Study | STARTED | Cohort B (Extranodal Extension) | 43 | |
| Overall Study | COMPLETED | Cohort A (Intermediate Risk) | 36 | |
| Overall Study | COMPLETED | Cohort B (Extranodal Extension) | 43 | |
| Overall Study | NOT COMPLETED | Cohort A (Intermediate Risk) | 2 | |
| Overall Study | NOT COMPLETED | Cohort B (Extranodal Extension) | 0 |
Source ClinicalTrials.gov
Adverse events66
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 | Dry mouth | Gastrointestinal disorders | Cohort A (Intermediate Risk) | 37 | 38 | 259 |
| other | Dry mouth | Gastrointestinal disorders | Cohort B (Extranodal Extension) | 42 | 43 | 305 |
| other | Dysphagia | Gastrointestinal disorders | Cohort A (Intermediate Risk) | 28 | 38 | 115 |
| other | Dysphagia | Gastrointestinal disorders | Cohort B (Extranodal Extension) | 36 | 43 | 130 |
| other | Esophagitis | Gastrointestinal disorders | Cohort A (Intermediate Risk) | 14 | 38 | 21 |
| other | Esophagitis | Gastrointestinal disorders | Cohort B (Extranodal Extension) | 15 | 43 | 25 |
| other | Mucositis oral | Gastrointestinal disorders | Cohort A (Intermediate Risk) | 23 | 38 | 35 |
| other | Mucositis oral | Gastrointestinal disorders | Cohort B (Extranodal Extension) | 28 | 43 | 41 |
| other | Nausea | Gastrointestinal disorders | Cohort A (Intermediate Risk) | 18 | 38 | 25 |
| other | Nausea | Gastrointestinal disorders | Cohort B (Extranodal Extension) | 13 | 43 | 17 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A (Intermediate Risk) | 0 | 38 |
| Total, all-cause mortality | Cohort B (Extranodal Extension) | 1 | 43 |
| Total, other adverse events | Cohort A (Intermediate Risk) | 38 | 38 |
| Total, other adverse events | Cohort B (Extranodal Extension) | 43 | 43 |
| Total, serious adverse events | Cohort A (Intermediate Risk) | 5 | 38 |
| Total, serious adverse events | Cohort B (Extranodal Extension) | 5 | 43 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31163012 | 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 |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort A (Intermediate Risk) vs Cohort B (Extranodal Extension): deaths from any cause | Trial comparisons |
| Cohort A (Intermediate Risk) vs Cohort B (Extranodal Extension): 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/NCT01932697
GET https://conductscience.org/api/trials/v1/NCT01932697/events?page=2