Combined therapy for resectable head and neck cancer. A phase 3 intergroup study

Arch Otolaryngol Head Neck Surg. 1989 Mar;115(3):364-8. doi: 10.1001/archotol.1989.01860270106023.

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Antineoplastic Agents / adverse effects
  • Clinical Trials as Topic
  • Combined Modality Therapy
  • Humans
  • Laryngeal Neoplasms / drug therapy*
  • Laryngeal Neoplasms / radiotherapy
  • Laryngeal Neoplasms / surgery
  • Mouth Neoplasms / drug therapy*
  • Mouth Neoplasms / radiotherapy
  • Mouth Neoplasms / surgery
  • Multicenter Studies as Topic
  • Pharyngeal Neoplasms / drug therapy*
  • Pharyngeal Neoplasms / radiotherapy
  • Pharyngeal Neoplasms / surgery
  • Prospective Studies
  • Radiotherapy / adverse effects
  • Random Allocation

Substances

  • Antineoplastic Agents