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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
Phase II/III Secondary Objectives
- Phase II:
- Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors;
- Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin.
- Phase III: Compare overall survival rates among patients receiving cisplatin and radiationto those receiving radiation alone.
- Compare the acute toxicities of these 2 adjuvant treatments;
- Compare late treatment-related adverse events in patients receiving postoperative radiation to those receiving concurrent chemoradiation;
- Compare progression-free survival rates among patients receiving cisplatin and radiation to those receiving radiation alone in both the cohort of patients with pathologically high-risk disease (high-grade adenocarcinoma, high-grade mucoepidermoid carcinoma, salivary duct carcinoma), and the patient cohort with pathologically intermediate-risk disease (all other eligible diagnoses).
- Investigate quality of life and patient-reported outcomes in patients enrolled in the study;
- Identify the histopathology and tumor marker expression from patients enrolled on this trial and assemble a tissue bank for future correlative studies;
- Establish an NRG Oncology baseline database for salivary gland malignancies to serve as a resource for future exploration of innovative and/or targeted approaches for this disease.
- Pathologically proven diagnosis of a malignant major salivary gland tumor or malignant minor salivary gland tumor of the head and neck of the following histologic subtypes:
- intermediate-grade adenocarcinoma or intermediate-grade mucoepidermoid carcinoma;
- high-grade adenocarcinoma or high-grade mucoepidermoid carcinoma or salivary duct carcinoma;
- high-grade acinic cell carcinoma or high-grade (>30% solid component) adenoid cystic carcinoma.
Pathologic interpretation of salivary gland malignancies can be very difficult. Patients with diagnoses such as "undifferentiated or poorly differentiated carcinoma", "carcinoma-ex pleomorphic adenoma", "carcinoma NOS" and others should be considered for this trial. A rapid, anonymous photomicrograph review can be obtained from Dr. El-Naggar to assist in identifying appropriate patients for this trial. Institutions are urged to contact either Dr. Adelstein (firstname.lastname@example.org) or Dr. El-Naggar email@example.com) to expedite such a review.
- 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:
- History/physical examination within 8 weeks prior to registration;
- 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.
- Zubrod Performance Status 0-1;
- Age ≥ 18;
- CBC/differential obtained within 4 weeks prior to registration, with adequate bone marrow function defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,800 cells/mm³
- Platelets ≥ 100,000 cells/mm³
- Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
- Adequate renal and hepatic function within 4 weeks prior to registration;, defined as follows:
- Serum creatinine < 2.0 mg/dl;
- Total bilirubin < 2 x the institutional ULN;
- AST or ALT < 3 x the institutional ULN.
- Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential;
- Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment.
- All patients must have a Medical Oncology evaluation within 4 weeks prior to registration;
- Patients must be deemed able to comply with the treatment plan and follow-up schedule.
- Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for central review.
- Patients with residual macroscopic disease after surgery;
- 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);
- Prior systemic chemotherapy or radiation therapy for salivary gland malignancy; note that prior chemotherapy for a different cancer is allowable;
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
- Transmural myocardial infarction within the last 6 months;
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; Note, however, coagulation parameters are not required for entry into this protocol.
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
- Pre-existing ≥ grade 2 neuropathy;
- Prior organ transplant.
- 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 because the treatment involved in this study may be significantly teratogenic;
- Significant pre-existing hearing loss, as defined by the patient or treating physician.
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