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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
Arm 2 consists of panitmumab plus RT
Cisplatin
Local Regional Control Rate at 2 Years
Kaplan-Meier estimate of Local regional control rate at 2 years. Local regional control rate will be measured according to the investigator's assessment of disease status based on all available data (ie, from clinical examination, radiologic assessments, pathology reports, and autopsy reports).
Time frame: from study day 1 to 2 years
Duration of Local Regional Control
Time from study day 1 to the date of first local-regional failure or to death due to any cause (whichever occurs first)
Time frame: maximum follow up time 46.2 months
Progression-free Survival
Time from first dose date till disease progression or death
Time frame: maximum follow up time 46.2 months
Overall Survival
Time from first dose date to death
Time frame: maximum follow up time 46.2 months
ORR by 6 Months - Central
ORR is Objective Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete or partial response is considered as objective response.
Time frame: From randomization to 6 months
CRR by 6 Months - Central
CRR is Complete Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete Response (CR) is defined as disappearance of all index lesions.
Time frame: From randomization till 6 months
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