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A Phase 3 Intergroup Study

David E. Schuller, MD; George Laramore, PhD, MD; Muhyi Al-Sarraf, MD; John Jacobs, MD; Thomas F. Pajak, PhD

Arch Otolaryngol Head Neck Surg. 1989;115(3):364-368.

Abstract
• This Head and Neck Intergroup (Radiation Therapy Oncology Group, Southwest Oncology Group, Eastern Cooperative Oncology Group, Cancer and Leukemia Group B, Northern California Oncology Group, and Southeastern Cancer Study Group) phase 3 randomized prospective trial was opened for registration January 1985. It is an evaluation of the role of chemotherapy for previously untreated advanced stage resectable squamous cell carcinoma of the head and neck. As of March 1, 1988, there has been a total of 535 patients registered. There are 266 patients analyzable with 133 in each treatment group. The surgical, chemotherapy, and radiation therapy toxic reactions are in the tolerable range with the worst toxic reactions reported in those patients receiving both surgery and radiation therapy. Compliance continues to be a major challenge to patient accrual. The most common cause for cases not being randomized involves positive margins of surgical resection. Patient refusal or surgical complications are other common reasons.

(Arch Otolaryngol Head Neck Surg 1989;115:364-368)

Author Affiliations
From the Department of Otolaryngology, Ohio State University, Columbus (Dr Schuller); the University of Washington, Seattle (Dr Laramore); Wayne State University, Detroit (Drs Al-Sarraf and Jacobs); and the Radiation Therapy Oncology Group, Philadelphia (Dr Pajak).

Footnotes
Accepted for publication Sept 20, 1988.

Read before the Second International Conference on Head and Neck Cancer, Boston, Aug 1, 1988.

Reprint requests to Department of Otolaryngology, Ohio State University, 456 W Tenth Ave, Columbus, OH 43210 (Dr Schuller).

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