Radiation with or without Chemotherapy for Head & Neck

RTOG 1008 - A Randomized Phase II/III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors.

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Quintiliani, Jennifer

    Trial Phone: 321.843.2026

  • IRB No: 11.022.04

    Protocol Abbrev: RTOG 1008

    Principal Investigator: Rafael R. Manon, MD

    Sub Investigators: Harris, Kendra MD; Johnson, Tirrell MD; Neely, Lindsey ARNP; Rineer, Justin MD; Tseng, Jennifer MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: RTOG 1008

    Treatment: Chemotherapy

    Applicable Disease Sites: Head and Neck

    Therapies Involved: Drug: cisplatin Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy

    ClinicalTrials.gov ID: NCT01220583

  • Objective

    This trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with malignant salivary gland tumors that have been removed by surgery.

  • Key Eligibility

    Must have pathologically proven diagnosis of a malignant major salivary gland tumor or malignant minor salivary gland tumor of the head and neck of the following histologic subtypes: 1. intermediate-grade adenocarcinoma or intermediate-grade mucoepidermoid carcinoma;
    2. high-grade adenocarcinoma or high-grade mucoepidermoid carcinoma or salivary duct carcinoma; 3. high-grade acinic cell carcinoma or high-grade (>30% solid component) adenoid cystic carcinoma. Must have surgical resection with curative intent within 8 weeks prior to registration. Must have pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤1mm) or microscopically
    positive surgical margin; patients must be free of
    distant metastases. Must not have residual macroscopic disease after surgery