NCT01220583

Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors. PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.

Detailed description

OBJECTIVES: Primary Phase II * Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors. * Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin. Phase III \* Compare overall survival rates among patients receiving cisplatin and radiation to those receiving radiation alone. Secondary Phase II/III * Compare the acute toxicities of these 2 adjuvant treatments. * Compare late treatment-related adverse events in patients receiving postoperative radiation to those receiving concurrent chemoradiation. * Compare progression-free survival rates among patients receiving cisplatin and radiation to those receiving radiation alone in both the cohort of patients with pathologically high-risk disease (high-grade adenocarcinoma, high-grade mucoepidermoid carcinoma, salivary duct carcinoma), and the patient cohort with pathologically intermediate-risk disease (all other eligible diagnoses). * Investigate quality of life and patient-reported outcomes in patients enrolled in the study. * Identify the histopathology and tumor marker expression from patients enrolled on this trial and assemble a tissue bank for future correlative studies. * Establish a NRG Oncology baseline database for salivary gland malignancies to serve as a resource for future exploration of innovative and/or targeted approaches for this disease. OUTLINE: This is a multicenter study. Patients are stratified according to histology (high-grade mucoepidermoid carcinoma vs salivary duct carcinoma vs high-grade adenocarcinoma) and nodal status (N0 vs N1-3). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) 5 days a week for 6-6.5 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiotherapy. * Arm II: Patients undergo 3D-CRT or IMRT as in Arm I. Tissue and blood samples may be collected for translational research studies. Patients may complete quality-of-life assessments periodically. After completion of study treatment, patients are followed up at 3, 6, 9, 12, and 24 months, every 6 months for 2 years, and then annually thereafter.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	cisplatin	Given IV
RADIATION	3-dimensional conformal radiation therapy	Undergo radiotherapy
RADIATION	intensity-modulated radiation therapy	Undergo radiotherapy

Timeline

• Start date: 2011-01-01
• Primary completion: 2026-10-31
• Completion: 2028-10-01
• First posted: 2010-10-14
• Last updated: 2025-02-13

Locations

268 sites across 3 countries: United States, Canada, Saudi Arabia