Overview

This trial is active, not recruiting.

Condition oropharyngeal neoplasms
Treatments intensity-modulated radiation therapy (imrt), cisplatin
Phase phase 3
Sponsor Washington University School of Medicine
Start date January 2013
End date October 2018
Trial size 41 participants
Trial identifier NCT01687413, 201207059

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions). 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
intensity-modulated radiation therapy (imrt)
(Active Comparator)
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions) Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2). 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
intensity-modulated radiation therapy (imrt)
cisplatin CACP, CDDP, CPDD, DDP, Neoplatin

Primary Outcomes

Measure
Disease-free survival (DFS)
time frame: 2 years
Locoregional control
time frame: 2 years

Secondary Outcomes

Measure
Distant metastasis rates
time frame: Up to 5 years
Disease specific survival
time frame: Up to 5 years
Cumulative incidence of complications/acute toxicity
time frame: 4.5 months
Function and quality of life (QOL)
time frame: Up to 24 months

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - Patient must have histologically confirmed p16 positive squamous cell carcinoma of the oropharynx (OPSCC). - Patient must have undergone transoral resection of their T1-4a oropharynx primary to a negative margin, and a neck dissection(s). - Patient's disease must be pathological N-stage positive. - Patient's disease must show extracapsular spread (ECS) in their nodal metastasis verified by central pathologist's review. - Patients with synchronous primaries are included. - Patients with unknown primaries are included if the diagnosis and resection of a primary site in the oropharynx is made from an endoscopic or robotic surgical procedure(s). - Patients with recent excisional node biopsies/neck dissections are included if material is evaluable for extracapsular spread. - Patient must be ≥ 21 years of age. - ECOG performance status ≤ 2 (Karnofsky ≥60%). - Patients must have normal organ and marrow function as defined below: - leukocytes ≥3,000/mcL - absolute neutrophil count ≥1,500/mcL - platelets ≥100,000/mcL - total bilirubin <1.5 X upper normal institutional limit - AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal - creatinine within normal institutional limits OR creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal - Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document. Exclusion Criteria: - Patient must not have pathologically N stage negative disease. - Patient must not have outside nodal tissue from previous neck biopsy/neck dissections in which ECS cannot be confirmed or denied. - Patient must not have a true unknown primary in which permanent section results are negative for malignancy in completely excised ipsilateral oropharyngeal tissue (palatine and lingual tonsil). - Patient must not have distant metastatic disease at presentation. - Patient must not have gross residual and/or microscopic disease present after surgery including re-resection(s), per the operative and pathology report. - Patient must not have transoral robotic surgery (TORS) for a T3 or T4 primary tumor. - Patient must not have a history of prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (for example, carcinoma in situ of the oral cavity, larynx, breast or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago. - Patient must not have had previous systemic chemotherapy for the study cancer. (Note: prior chemotherapy for a different cancer is allowable). - Patient must not be receiving any other investigational agents. - Patient must not have had any prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields - Patient must not have any life-threatening comorbid illnesses e.g. stroke with major sequelae or myocardial infarction/ unstable angina within the preceding 3 months or psychiatric illness/social situations that would limit compliance with study requirements. - Patient must not be pregnant or breastfeeding. If a woman of childbearing potential, patient must agree to use medically acceptable forms of contraception. Both men and women and members of all races and ethnic groups are eligible for this trial.

Additional Information

Official title Adjuvant De-escalation, Extracapsular Spread, P16+, Transoral (ADEPT) Trial for Oropharynx Malignancy
Principal investigator Jason Rich, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.
Location data was received from the National Cancer Institute and was last updated in June 2016.