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

Official Title

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

Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumour cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumour 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 tumours. 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 tumours that have been removed by surgery.

Trial Description

Primary Outcome:

• Progression-free survival (PFS), defined by the events of local-regional progression or recurrence, distant metastasis, or death from any cause, primarily at 2 years

• Overall survival (OS) rate at 2 years
• PFS rate at 5 years
• OS rate at 5 years
• Treatment-related toxicity, defined as any grade 3-4 adverse events (CTCAE v. 4) deemed to be definitely, probably, or possibly related to protocol treatment
• Treatment-related mortality, defined as any death during or within 30 days of discontinuation of protocol treatment
• Chemotherapy delivery as measured by percentage of protocol prescription given
• Radiation delivery as measured by elapsed treatment days
• Determine whether quality of life, fatigue and xerostomia differ as a function of treatment assignment at 3, 12, and 24 months after completing radiation therapy.

• Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumours.

• Acquire preliminary efficacy data comparing postoperative radiation therapy 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 tumour 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 multicentre 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 radiation therapy (3D-CRT) or intensity-modulated radiation therapy (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 radiation therapy.

• 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.

View this trial on ClinicalTrials.gov