Protocol Title:

A Phase III Randomized Study to Compare Twice Daily Hyperfractionation, Accelerated Hyperfractionation with a Split and Accelerated Fractionation with Concomitant Boost, to Standard Fractionation Radiotherapy for Squamous Cell Carcinomas of the Head and Neck

Protocol Status:

Closed

Protocol Number:

R 9003

Type of Cancer:

Head and neck cancer (squamous cell carcinoma)

Principal Investigator:

Ding-Jen Lee, M.D.

Phase Number:

III

Summary:

One thousand one hundred thirteen patients were entered on the national study. Six patients were accessioned by Johns Hopkins. This trial closed to Accrual on 08/01/97. Two patients are alive and continue in follow-up (one of these patients completed his study therapy in 1992 while the other completed her therapy in 1993).
The correlative study in a large series of patients revealed that EGFR expression, which varied considerably among head and neck small cell carcinoma patients, was not a strong independent prognostic indicator for distant metastasis. The data suggest that EGFR IHC should be considered for selecting patients for more aggressive combined therapies or enrollment into trials targeting EGFR signaling pathways.