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Protocol No. RTOG1008

Principal Investigator Harari, Paul

Phase II/III

Age Group Adult

Scope National

Sponsor Type National

Title A randomized phase II/phase III study of adjuvant concurrent radiation and chemotherpay versus radiation alone in resected high-risk malignant salivary gland tumors

Objective 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.

Treatment Group 1: 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 Group 2: You will receive daily radiation for up to 7 weeks

Description
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


Key Eligibility
  • 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

    Therapies Involved Cytotoxic Chemotherapy; Radiotherapy

    Drugs Involved cis-diamminedichloroplatinum (cisplatin); cisplatin; platinol (cisplatin); platinum (cisplatin)

    Status Open

    Participating Institutions Johnson Creek, UW Cancer Center; UW Hospital and Clinics