Cancer Clinical Trial
Official title:
A Phase 2 Randomized Trial of Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck
The purpose of this study is to estimate, with pre-specified precision, the difference in local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT) or panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous cell carcinoma for the head and neck (SCCHN). A formal hypothesis will not be tested in this trial; however, the treatment arm difference in LRC rates at 2 years will be estimated.
Primary Objective: To estimate, with pre-specified precision, the difference in
local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT)
or panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous
cell carcinoma for the head and neck (SCCHN).
Secondary Objectives: To estimate the difference between 2 treatment regimens (CRT vs PRT)
on other measures of clinical benefit, including LRC, overall response rate (ORR),
progression-free survival (PFS), overall survival (OS); and safety.
Tertiary Objectives: To estimate the difference in health-related quality of life (HRQoL)
and performance status in subjects receiving PRT or CRT.
Exploratory Objectives: To investigate potential biomarker development based on assessment
of blood and tumor and the proposed mechanism of actions of study drugs. In addition, to
investigate the effect of genetic variation in cancer genes and drug target genes on SCCHN
and subject response to study drugs (separate informed consent required).
Hypothesis: A formal hypothesis will not be tested in this trial; however, the treatment arm
difference in LRC rates at 2 years will be estimated.
Study Design: This is a phase 2, open-label, randomized, multicenter study. Eligible
subjects will be randomized in a 2:3 ratio to either of the following regimens:
Arm 1 CRT:
- Accelerated fractionation RT: 70 to 72 Gy - delivered over 6 to 6.5 weeks
- Cisplatin: 100 mg/m2 (given on days 1 and 22 of RT) or
Arm 2 PRT:
- Accelerated fractionation RT: 70 to 72 Gy - delivered over 6 to 6.5 weeks
- Panitumumab: 9.0 mg/kg Q3W (given on days 1, 22, and 43 of RT)
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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