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

General Information

Age Group

Adult

Status

Recruiting

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

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT01220583