a randomized phase ii study of adjuvant concurrent radiation and chemotherapy versus radiation alone in resected high-risk malignant salivary gland tumors

Conditions: Malignant Salivary Gland Tumors

Summary: a randomized phase ii study of adjuvant concurrent radiation and chemotherapy versus radiation alone in resected high-risk malignant salivary gland tumors


Eligibility criteria:
inclusion criteria: 1. pathologically proven diagnosis of a malignant major salivary gland tumor of the following histologic subtypes: high grade mucoepidermoid carcinoma, salivary duct carcinoma or high grade adenocarcinoma; 2. surgical resection with curative intent within 8 weeks prior to registration; 3. pathologic stage t3-4 or n1-3 or t1-2, n0 with a close (≤1mm) or microscopically positive surgical margin (ajcc, 7th ed.; see appendix iv); patients must be free of distant metastases based upon the following minimum diagnostic workup: 4. zubrod performance status 0-1; 3.1.5 age ≥ 18; 3.1.6 cbc/differential obtained within 4 weeks prior to registration, with adequate bone marrow function 3.1.7 adequate renal and hepatic function within 4 weeks prior to registration 3.1.8 negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential; 3.1.9 women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment. 3.1.10 patients must be deemed able to comply with the treatment plan and follow-up schedule. exclusion criteria: 3.2.1 patients with residual macroscopic disease after surgery; 3.2.2 patients with salivary gland malignancies originating from the minor salivary glands; 3.2.3 patients with histologies other than high grade mucoepidermoid carcinoma, high grade adenocarcinoma or salivary duct carcinoma; 3.2.4 prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible); 3.2.5 prior systemic chemotherapy or radiation therapy for salivary gland malignancy; note that prior chemotherapy for a different cancer is allowable; 3.2.6 prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; 3.2.7 severe, active co-morbidity, defined as follows: 3.2.7.1 unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; 3.2.7.2 transmural myocardial infarction within the last 6 months; 3.2.7.3 acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; 3.2.7.4 chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; 3.2.7.5 hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, coagulation parameters are not required for entry into this protocol. 3.2.7.6 acquired immune deficiency syndrome (aids) 3.2.7.7 pre-existing ≥ grade 2 neuropathy; 3.2.7.8 prior organ transplant. 3.2.8 pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary; 3.2.9 significant pre-existing hearing loss, as defined by the patient or treating physician.