Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer (ADEPT)
|ClinicalTrials.gov Identifier: NCT01687413|
Recruitment Status : Active, not recruiting
First Posted : September 18, 2012
Last Update Posted : September 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Oropharyngeal Neoplasms||Radiation: Intensity-modulated radiation therapy (IMRT) Drug: Cisplatin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant De-escalation, Extracapsular Spread, P16+, Transoral (ADEPT) Trial for Oropharynx Malignancy|
|Actual Study Start Date :||January 10, 2013|
|Estimated Primary Completion Date :||May 31, 2018|
|Estimated Study Completion Date :||May 31, 2018|
||Radiation: Intensity-modulated radiation therapy (IMRT)|
Active Comparator: Radiotherapy, cisplatin
Radiation: Intensity-modulated radiation therapy (IMRT)
Other Name: CACP, CDDP, CPDD, DDP, Neoplatin
- Disease-free survival (DFS) [ Time Frame: 2 years ]Survival probability will be estimated by Kaplan-Meier analysis and survival curves for patients with adjuvant radiotherapy w and w/o chemotherapy will be compared by use of log-rank statistic.
- Locoregional control [ Time Frame: 2 years ]Rate of patients with no recurrence at original oropharyngeal site or in the neck nodal basins.
- Distant metastasis rates [ Time Frame: 2 years ]Assessed by biopsy or imaging-detected recurrent disease at sites away from the original primary and cervical zone.
- Disease specific survival [ Time Frame: 2 years ]Defined as time from surgery to death from recurrent oropharyngeal cancer or treatment-related death.
- Cumulative incidence of complications/acute toxicity [ Time Frame: 4.5 months ]Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Function and quality of life (QOL) [ Time Frame: 2 years ]Multiplicity corrected tests for trend (i.e., non-parametric Jonckehere-Terpstra test) used to compare patients with adjuvant radiotherapy w/ and w/o chemotherapy at single time points (study entry 1, 3, 6, 12 and 24 months).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687413
|United States, Arizona|
|Mayo Clinic Scottsdale|
|Scottsdale, Arizona, United States, 85259-5499|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Jason Rich, MD||Washington University School of Medicine|