Clinical Trial ID: NCT01220583
A Randomized Phase II/Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
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.
The primary objective for phase II is to determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors and to acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin. The primary objective of the phase III is to compare overall survival rates among patients receiving cisplatin and radiation to those receiving radiation alone.
Experimental: 3D-CRT/IMRT + 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.
Active Comparator: 3D-CRT/IMRT
Patients undergo 3D-CRT or IMRT as in arm I.
Baptist MD Anderson Cancer Center
- Surgical resection with curative intent within 8 weeks prior to registration
- All patients must have a Medical Oncology evaluation within 4 weeks prior to registration
- No patients with residual macroscopic disease after surgery
- No prior systemic chemotherapy or radiation therapy for salivary gland malignancy
- Zubrod performance status 0-1
- Absolute neutrophil count (ANC) ≥ 1,800 cells/mm^3
- Platelets ≥ 100,000 cells/mm^3
- Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL is acceptable)
- Serum creatinine < 2.0 mg/dL
- Total bilirubin < 2 x the institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the institutional ULN
- Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential
- Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment
- Not pregnant or nursing
- Patients must be deemed able to comply with the treatment plan and follow-up schedule
- Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for central review
- No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
- No prior systemic chemotherapy or radiation therapy for salivary gland malignancy (prior chemotherapy for a different cancer is allowable)
- No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- No prior organ transplant
- No concurrent hematopoietic growth factors (e.g., G-CSF or pegfilgrastim) during radiotherapy
- No concurrent erythropoiesis-stimulating agents
- No significant pre-existing hearing loss, as defined by the patient or treating physician
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