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Clinical Trial 18612
Study Type: Treatment
Phase of Study: Phase II/III
- Jimmy Caudell
A Randomized Phase II/III Study of Adjuvant Concurrent Radiation and Chemotherapy versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
The purpose of this study is to test whether the use of chemotherapy with radiation will improve the results compared to surgery and radiation alone.
NOTE: Phase II is complete. Phase II: 1. Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors; 2. Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin. Phase III: 1. Compare overall survival rates among patients receiving cisplatin and radiation to those receiving radiation alone. Phase II/III Secondary Objectives: 1. Compare the acute toxicities of these 2 adjuvant treatments; 2. Compare late treatment-related adverse events in patients receiving postoperativeradiation to those receiving concurrent chemoradiation; 3. 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). 4. Investigate quality of life and patient-reported outcomes in patients enrolled in the study; 5. Identify the histopathology and tumor marker expression from patients enrolled on this trial and assemble a tissue bank for future correlative studies; 6. Establish an 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.