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