Radiation Therapy with or Without Chemotherapy in Treating Patients with High-Risk Malignant Salivary Gland Tumors That Have Been Removed by Surgery
- Conditions
- Head and Neck Cancer
- Interventions
- Radiation: 3-dimensional conformal radiation therapyRadiation: intensity-modulated radiation therapy
- Registration Number
- NCT01220583
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 252
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I 3-dimensional conformal radiation therapy 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 3-dimensional conformal radiation therapy Patients undergo 3D-CRT or IMRT as in arm I. Arm I intensity-modulated radiation therapy 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 intensity-modulated radiation therapy Patients undergo 3D-CRT or IMRT as in arm I. Arm I cisplatin 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.
- Primary Outcome Measures
Name Time Method 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 From randomization to 2 years.
- Secondary Outcome Measures
Name Time Method 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 From start of treatment to last follow-up. Determine whether quality of life, fatigue and xerostomia differ as a function of treatment assignment at 3, 12, and 24 months after completing radiotherapy. From randomization to 2 years. Treatment-related mortality, defined as any death during or within 30 days of discontinuation of protocol treatment From start of treatment to 30 days after the end of treatment. Radiation delivery as measured by elapsed treatment days From start of treatment to end of treatment. PFS rate at 5 years From randomization to 5 years. Overall survival (OS) rate at 2 years From randomization to 2 years. OS rate at 5 years From randomization to 5 years. Chemotherapy delivery as measured by percentage of protocol prescription given From start of treatment to end of treatment.
Trial Locations
- Locations (268)
University of Alabama at Birmingham Cancer Center
🇺🇸Birmingham, Alabama, United States
The Kirklin Clinic at Acton Road
🇺🇸Birmingham, Alabama, United States
Arizona Breast Cancer Specialists-Gilbert
🇺🇸Gilbert, Arizona, United States
Arizona Center for Cancer Care-Peoria
🇺🇸Peoria, Arizona, United States
Cancer Center at Saint Joseph's
🇺🇸Phoenix, Arizona, United States
Arizona Breast Cancer Specialists-Phoenix
🇺🇸Phoenix, Arizona, United States
Arizona Oncology-Deer Valley Center
🇺🇸Phoenix, Arizona, United States
Arizona Breast Cancer Specialists
🇺🇸Scottsdale, Arizona, United States
Arizona Breast Cancer Specialists-Scottsdale
🇺🇸Scottsdale, Arizona, United States
Arizona Oncology Services Foundation
🇺🇸Scottsdale, Arizona, United States
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