Overview

Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Status:
Completed

Trial end date:
2012-03-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Amgen

Treatments:

Antibodies, Monoclonal
Cisplatin
Panitumumab

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed SCC of the oral cavity, oropharynx, hypopharynx
or larynx Stage III or Stage IVa-b (M0) disease according to the American Joint Committee
on Cancer staging manual 6th edition (locally advanced) ECOG performance status of 0 or 1
Bidimensionally measurable disease >/= 10 mm in at least 1 dimension

Exclusion Criteria:

NO Primary tumor of the nasopharynx, sinuses, salivary gland, or skin NO Subjects requiring
prophylactic tracheostomy NO Prior (or concomitant) malignancy (except non-melanomatous
skin cancer or in situ cervical cancer), other than the study disease (SCCHN), unless
treated with curative intent with no evidence of disease for >/= 3 years NO Prior treatment
for locally advanced SSCHN NO Prior surgery for SCCHN (except nodal sampling or biopsy for
study disease) NO Major surgery days before randomization with the exception of feeding tube placement, dental extractions,
central venous catheter placement, biopsies and nodal sampling