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A randomized phase II/phase III study of adjuvant concurrent radiation and chemotherpay versus radiation alone in resected high-risk malignant salivary gland tumors
The purpose of this study is to test whether the use of chemotherapy with radiation will further improve the results after surgery than with radiation alone. This study will compare the effects, good and/or bad, of radiation and chemotherapy with radiation alone on salivary gland cancer to find out which is better at reducing the chance that the cancer will come back.
You will receive daily radiation for up to 7 weeks with Cisplatin Chemotherapy through your veins every week for a total of 7 weeks during radiation
You will receive daily radiation for up to 7 weeks
Eligible participants will be randomize into one of the study groups described below. Randomization means that you are put into a group by chance, like flipping a coin. A computer program will place you in one of the study groups. Neither you nor your doctor can choose the group you will be in. You will have an equal chance of being placed in either group.
If you are in Group 1 (Arm I): You will receive radiation therapy once a day, Monday through Friday for about 6-7 weeks. Each treatment may take up to 30 minutes depending on the technique used. You will also receive a chemotherapy drug, cisplatin, through the vein, every week (before or after radiation), and you will receive a total of 7 treatments. The chemotherapy will take about 4 hours, including administration of medications to prevent nausea and to replace body fluids.
If you are in Group 2 (Arm II): You will receive radiation therapy once a day, Monday through Friday for about 6-7 weeks. Each treatment may take up to 30 minutes depending on the technique used.
Approximately 120 people will take part in this study nationally and it is expected that approximately 10 people will take part at the University of Wisconsin Hospital and Clinics.Click here for more info
Confirmed diagnosis of a malignant major salivary gland tumor.
One of the following subtypes: high grade mucoepidermoid carcinoma, salivary duct carcinoma, or high grade adenocarcinoma.
Must have had surgical resection with curative intent within 8 weeks of registration.
Must have one of the following high risk factors: Pathologic stage T3-4; Pathologic N1-3, T1-2, N0 with a close (1mm or less) or microscopically positive margin.
No distant metastases.
No prior chemotherapy or radiation for this cancer.
Applicable Disease Sites
Head and Neck
Cytotoxic Chemotherapy; Radiotherapy
cis-diamminedichloroplatinum (cisplatin); cisplatin; platinol (cisplatin); platinum (cisplatin)
Aspirus UW Cancer Center (formerly Riverview Hospital); Johnson Creek, UW Cancer Center; UW Hospital and Clinics