Radiation Oncology/RTOG Trials/0421

RTOG 04-21 (Head & Neck)

• Title: A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and chemotherapy versus chemotherapy alone
• Objective: To determine whether re-irradiation plus concurrent chemotherapy improves overall survival of patients with previously irradiated, non-metastatic, locally recurrent or new primary squamous cell carcinoma of the head and neck (SCCHN) as compared to conventional chemotherapy alone
• Protocol: Randomize to
  • Arm 1: RT + CT (RT 60 Gy in 1.5 Gy/fx on weeks 1, 3, 5, 7) + (Cisplatin/paclitaxel on weeks 1, 3, 5, 7) + (G-CSF on weeks 2, 4, 6, 8)
  • Arm 2: CT alone (select cisplatin/5-FU or cisplatin/paclitaxel or cisplatin/docetaxel)
• Eligibility:
  • Pathologically confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, larynx, or recurrent neck metastases with unknown primary
  • Patients must not be candidates for surgical resection.
• Enrollment Target: 240 patients
• Activation: April 27, 2005
• Closed: January 5, 2007 -- Closed due to poor accrual