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Head and Neck
General Information
Study Name:
Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery
Age Group:
Adult
Protocol Number:
NCT01220583
Background Information:
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.his 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.
Offered at:
Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital
Eligibility Information
Pathologically proven diagnosis of a malignant major salivary gland tumor of the following histologic subtypes:
High-grade mucoepidermoid carcinoma
Salivary duct carcinoma
High-grade adenocarcinoma
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
Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 1mm) or microscopically positive surgical margin; patients must be free of distant metastases based upon the following minimum diagnostic workup:
History/physical examination within 8 weeks prior to registration
Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration; at a minimum, contrast CT imaging of the chest is required (PET/CT is acceptable)
Additional eligibility in protocol
Ineligibility Information
No patients with residual macroscopic disease after surgery
No patients with salivary gland malignancies originating from the minor salivary glands
No patients with histologies other than high-grade mucoepidermoid carcinoma, high-grade adenocarcinoma, or salivary duct carcinoma
Additional ineligibility in protocol
Contact Information
Contact Name:
Kelly Jeffords, CCRP
Contact Phone:
571-472-0631
Contact Email:
kelly.jeffords@inova.org
Additional information can be found at:
https://clinicaltrials.gov/ct2/show/NCT01220583