This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.
PRIMARY OBJECTIVES: I. To evaluate the disease-free survival (DFS) of patients with stage III-IV squamous cell carcinoma of the head and neck (SCCHN) and disruptive p53 mutations after primary surgical resection followed by postoperative radiotherapy (PORT) alone or PORT with concurrent cisplatin. SECONDARY OBJECTIVES: I. 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. II. 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. III. To evaluate toxicities of PORT alone or PORT with concurrent cisplatin. IV. To evaluate p53 mutation as a predictive biomarker of survival benefit given post-operative concurrent radiation and cisplatin. V. To identify potential genomic alterations in addition to TP53 mutations that may be developed to a novel treatment approach. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients undergo intensity-modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. ARM B: Patients undergo IMRT QD 5 days a week and receive cisplatin intravenously (IV) over 1-2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 3 years and then every 12 months for 7 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
189
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
ACTIVE_NOT_RECRUITINGAnchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
SUSPENDEDAnchorage Radiation Therapy Center
Anchorage, Alaska, United States
SUSPENDEDAlaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
SUSPENDEDDisease-free survival in patients with stage III-IV disease and disruptive p53 mutation
Kaplan-Meier estimates will be used to estimate event-time distributions and comparison between arms will be performed using a log-rank test.
Time frame: Date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 10 years
Disease-free survival in patients with stage III-IV disease and non-disruptive p53 mutation
Kaplan-Meier estimates will be used to estimate event-time distributions and comparison between arms will be performed using a log-rank test.
Time frame: Date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 10 years
Disease-free survival in patients with stage III-IV disease and wild type p53 mutation
Kaplan-Meier estimates will be used to estimate event-time distributions and comparison between arms will be performed using a log-rank test.
Time frame: Date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 10 years
Incidence of adverse events graded using Common Terminology Criteria for Adverse Events version 4
Toxicity will be examined by arm and compared using the Fisher's exact test.
Time frame: Up to 6 weeks
p53 as a predictive marker of recurrence
To evaluate whether p53 is a predictive marker, a p53 by treatment arm interaction term will be tested in a Cox proportional hazards model.
Time frame: Baseline
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Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States
SUSPENDEDAlaska Women's Cancer Care
Anchorage, Alaska, United States
SUSPENDEDAnchorage Oncology Centre
Anchorage, Alaska, United States
SUSPENDEDKatmai Oncology Group
Anchorage, Alaska, United States
SUSPENDEDProvidence Alaska Medical Center
Anchorage, Alaska, United States
SUSPENDEDCancer Center at Saint Joseph's
Phoenix, Arizona, United States
ACTIVE_NOT_RECRUITING...and 630 more locations