A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors

Study Overview
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Brief Summary
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A Randomized Phase II study of Adjuvant Concurrent Radiation and Chemotherapy versus Radiation alone in Resected High-Risk Malignant Salivary Gland Tumors

Conditions
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Malignant Salivary Gland Tumors

Intervention / Treatment
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* Drug: Cisplatin: 40 mg/m2 weekly during radiation
* Radiation: Radiation: 60-66 Gy in 2 Gy daily fractions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Surgical resection with curative intent within 8 weeks prior to registration; 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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1:<br>Radiation: 60-66 Gy in 2 Gy daily fractions Cisplatin: 40 mg/m2 weekly during radiation for 7 doses | Drug: Cisplatin: 40 mg/m2 weekly during radiation<br>* Cisplatin: 40 mg/m2 weekly during radiation for 7 doses<br>|
| Active Comparator: Arm 2:<br>Radiation: 60-66 Gy in 2 Gy daily fractions | Radiation: Radiation: 60-66 Gy in 2 Gy daily fractions<br>* Radiation: 60-66 Gy in 2 Gy daily fractions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin. |  | Two years |