Radiation Therapy and Docetaxel in Treating Patients With HPV-Related Oropharyngeal Cancer
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|ClinicalTrials.gov Identifier: NCT01932697|
Recruitment Status : Active, not recruiting
First Posted : August 30, 2013
Results First Posted : September 18, 2019
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Docetaxel Radiation: Hyperfractionation Radiation: Intensity-Modulated Radiation Therapy Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment||Phase 2|
I. To assess the cumulative incidence of local/regional failure at 2 years after study registration.
I. To characterize the rate of acute grade 3 or higher functional mucosal adverse events (up to 1 month post-radiation therapy [XRT]) associated with adjuvant docetaxel + hyperfractionated radiotherapy (key secondary endpoint).
II. To assess changes in overall survival, disease-free survival, distant failure rates, and quality of life (QOL) associated with adjuvant docetaxel and hyperfractionated radiation.
III. To characterize other acute adverse events (up to 1 month post-XRT) and late grade 3 or higher non-hematologic adverse events (up to 2 years post-XRT) associated with adjuvant docetaxel + hyperfractionated radiotherapy.
I. To determine the genetic alterations of oropharynx tumor specimens and the detection rate of corresponding cell-free deoxyribonucleic acid (cfDNA) in the pre-surgical, post-surgical, and post-radiation blood of oropharynx cancer patients.
Patients receive docetaxel intravenously (IV) over 1 hour on days 1 and 8 and undergo hyperfractionated intensity-modulated radiation therapy (IMRT) twice daily (BID) 5 days a week on days 1-12 for a total of 20 fractions.
After completion of study treatment, patients are followed up at 14 days, 1 month, every 3 months for 2 years, every 6 months for 1 year and then annually for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Evaluation of Adjuvant Hyperfractionated Radiation and Docetaxel for HPV Associated Oropharynx Cancer|
|Actual Study Start Date :||September 2013|
|Actual Primary Completion Date :||June 13, 2018|
|Estimated Study Completion Date :||October 2019|
Experimental: Treatment (docetaxel, hyperfractionated IMRT)
Patients receive docetaxel IV over 1 hour on days 1 and 8 and undergo hyperfractionated IMRT BID 5 days a week on days 1-12 for a total of 20 fractions.
Undergo hyperfractionated IMRT
Radiation: Intensity-Modulated Radiation Therapy
Undergo hyperfractionated IMRT
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
- 2-year Loco-regional Tumor Control (LRC) Rate [ Time Frame: Up to 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.
- Incidence of Grade 3 or Higher Mucositis Oral [ Time Frame: Up to 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.
- 2-year Overall Survival (OS) Rate [ Time Frame: From registration to death due to any cause, assessed up to 2 years ]The distribution of OS will be estimated using the method of Kaplan-Meier.
- 2-year Progression-free Survival (PFS) [ Time Frame: 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.
- 2-year Distant Metastasis-free Survival Rate [ Time Frame: Up to 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.
- Change From Baseline to 12 Months Post-RT in Swallow Function as Measured by the Pharyngeal Total Modified Barium Swallow Impairment Profile [ Time Frame: Baseline to up to 12 months post-treatment ]Swallowing will be scored (yes, no) for aspiration, penetration, velopharyngeal incompetence, epiglottic inversion, tongue base retraction, and pharyngeal swallow response using the metric outlined by Eisbruch et al.
- 1 Year Post-treatment in QOL Measured Using the Functional Assessment of Cancer Therapy Head and Neck (FACT H& N) (Version 4) [ Time Frame: 1 year post-treatment ]1 year post-treatment in QOL measured using the Functional Assessment of Cancer Therapy Head and Neck (FACT H& N) (version 4)
- 1-year Post-treatment QOL as Measured by the European Organization for Research and Treatment for Cancer QOL Questionnaire for Head and Neck Cancer Module 35 (EORTC-QLQ HN35) [ Time Frame: 1 year post-treatment ]1-year post-treatment QOL as measured by the 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 as Measured by the Three-level Version of the EuroQol Five-dimensional Instrument (EQ-5D-3L) [ Time Frame: 1 year post-treatment ]1-year post-treatment QOL as measured by the three-level version of the EuroQol five-dimensional instrument (EQ-5D-3L)
- Changes in Transforming Growth Factor (TGF)-beta1 Levels [ Time Frame: 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.
- E6/E7 Messenger Ribonucleic Acid (mRNA) of HPV16, Assessed on a Chromogenic RNA in Situ Hybridization (ISH) Assay Called RNAscope [ Time Frame: Baseline ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932697
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Daniel Ma||Mayo Clinic|