Study ID: RTOG 1008
This trial is studying the effectiveness of using chemotherapy and radiation therapy compared to radiation alone in treating salivary gland tumors.
Radiation therapy uses X-rays to kill cancer cells, while chemotherapy (cancer drugs) can stop the growth of cancer cells by killing them or preventing them from dividing further. The purpose of this study is to see if patients who have had malignant salivary gland tumors surgically removed can benefit from radiation therapy—three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiation therapy (IMRT)—plus cisplatin (a chemotherapy drug) vs. radiation therapy alone.
Patients will be randomized to receive radiation therapy plus chemo or radiation therapy alone. To be included in this trial, patients must be willing to receive all required testing. This includes a contrast CT scan of the chest to rule out the spread of cancer. Patients must also be willing to receive all therapies as required and to attend follow-up appointments.
A randomized phase II/phase III study of adjuvant concurrent radiation and chemotherapy vs. radiation alone in resected high-risk malignant salivary gland tumors
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 and history/physical within eight weeks prior to registration
Medical oncology evaluation within four 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: 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)
No residual macroscopic disease after surgery; salivary gland malignancies originating from the minor salivary glands and histologies other than high-grade mucoepidermoid carcinoma, high-grade adenocarcinoma, or salivary duct carcinoma.
Intervention/treatment: 3D-CRT or IMRT 5x week for 6 to 6.5 weeks. Cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiotherapy
3D-CRT or IMRT 5x week for 6 to 6.5 weeks
- Must have pathologically proven diagnosis (diseased tissue examined in a lab) of a malignant major salivary gland tumor
- Must have had surgical resection (removal or partial removal) of malignant salivary glands within eight weeks before trial registration
- Must have a medical oncology evaluation within four weeks before trial registration