Clinical Trial: Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Adjuvant De-escalation, Extracapsular Spread, P16+, Transoral (ADEPT) Trial for Oropharynx Malignancy
Brief Summary: This clinical trial studies the intensity of adjuvant ("helper") therapy required in p16 positive oropharynx cancer patients, who have had all known disease removed surgically by a minimally invasive approach, and who have extracapsular spread in their lymph nodes. Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways. After the surgery, receive either radiation alone, or radiation and weekly cis-platinum during therapy. Patients are then followed for cancer, functional and quality of life outcomes.
Detailed Summary:
Sponsor: Washington University School of Medicine
Current Primary Outcome:
- 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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).
Original Secondary Outcome:
- Distant metastasis rates [ Time Frame: Up to 5 years ]Assessed by biopsy or imaging-detected recurrent disease at sites away from the original primary and cervical zone.
- Disease specific survival [ Time Frame: Up to 5 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: Up to 24 months ]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).
Information By: Washington University School of Medicine
Dates:
Date Received: September 13, 2012
Date Started: January 10, 2013
Date Completion: May 31, 2018
Last Updated: February 2, 2017
Last Verified: February 2017