Protocol Title:

Phase III Intergroup Trial of Surgery Followed by (1) Radiotherapy vs. (2) Radiochemotherapy for Resectable High Risk Squamous Cell Carcinoma of the Head and Neck

Protocol Status:

Closed

Protocol Number:

R 9501

Type of Cancer:

Squamous cell carcinoma of the glottic and supraglottic larynx.

Principal Investigator:

Danny Song, M.D.

Phase Number:

III

Summary:

Four Hundered and forty -nine patients have been accessioned to this national study. Five patients have been accessioned by Johns Hopkins. Two patients were randomized to ARM I (RT alone) and 3 patients were randomized to ARM II (RT Plus Cisplatin). The first patient assigned to ARM I completed his treatment in 1997 but relasped and expired in 10/98 due to disease related illness. The second patient assinged to ARM I completed his protocol therapy in 1999 however he expired in 7/2001. The first patient assigned to ARM II completed protocol treatment in 1996 and is alive but unfortuately developed metastatic disease to the breast, the second patient assigned to ARM II completed protocol treatment in 1997 and is alive disease free. The third patient assigned to ARM II completed his protocol treatment in 11/97 and expired on 02/02/1998 (cause unknown). This trial closed to accrual on 04/28/2000 - and we are renewing the trial for follow-up only. The data we are collecting is based on assessments that are part of the patients standard care.