Page 11 - Delaware Medical Journal - March/April 2019

ECOG-ACRIN EA3132: Phase II Randomized Trial Of Adjuvant Radiotherapy With Or Without Cisplatin For P53 Mutated, Surgically Resected Squamous Cell Carcinoma Of The Head And Neck
The objectives of the trial are:
Primary Objective:
• To evaluate the disease-free survival (DFS) of patients with stage III-IV SCCHN and disruptive p53 mutations after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin.
Secondary Objective:
• To evaluate the DFS of patients with stage III-IV SCCHN and non-disruptive p53 mutations after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin
• To evaluate the DFS of patients with stage III-IV SCCHN and p53 wild type after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin
• To evaluate toxicities of PORT alone or PORT with concurrent cisplatin.
• To evaluate p53 mutation as a predictive biomarker of survival benefit given post-operative concurrent radiation and cisplatin.
• To identify potential genomic alterations in addition to TP53 mutations that may be developed to a novel treatment approach.
Eligibility:
Pre-Registration STEP 0:
• Age ≥ 18 years
• Pathologically proven diagnosis of squamous cell carcinoma of the head/neck pathologic stage III or IVA (AJCC 8); T3-T4a, N0-3, M0 or T1-T2, N1-3, M0.
• Patient has undergone total resection of the primary tumor with curative intent.
• For oropharynx primary tumors, the patient must have negative HPV status of the tumor as determined by p16 protein expression using immunohistochemistry.
• A paraffin-embedded surgical tumor tissue specimen has been located and is available for shipment to Foundation Medicine, Inc. following pre- registration.
• Patients with a history of a curatively treated malignancy must be disease-free for at least two years. Patients must not have received chemotherapy or investigational therapy within two years of surgical resection of the primary tumor.
• Patient must not have had previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease.
Registration STEP 1:
• Patient may not be randomized until site has been notified that the central determination of p53 mutation status of the surgical tumor tissue has been completed and site has been notified of assay completion.
• Per the operative report, the gross total resection of the primary tumor with curative intent was completed within 8 weeks prior to randomization.
• Patient has ECOG Performance Status 0-1 within 2 weeks prior to randomization.
• Females of childbearing potential must have a blood or urine study within 2 weeks prior to randomization to rule out pregnancy.
• Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and until 60 days from the last study treatment.
• Acceptable CBC, chemistries, renal and hepatic function within 4 weeks prior to randomization.
Treatment:
• Arm A: RT 60 Gy IMRT
• Arm B: RT 60 Gy IMRT & Cisplatin 40mg/m2 x 6 weeks
For information regarding this clinical trial or if you would like to have the list of open protocols emailed to you, please call the Cancer Research Office at (302) 623-4450 or email akee@christianacare.org.
CANCER CLINICAL TRIAL
Del Med J | March/April 2019 | Vol. 91 | No. 2 59