RTOG 1008 A RANDOMIZED PHASE II STUDY OF ADJUVANT CONCURRENT RADIATION AND CHEMOTHERAPY VERSUS RADIATION ALONE IN RESECTED HIGH-RISK MALIGNANT SALIVARY GLAND TUMORS
This randomized phase II study is an unprecedented effort that primarily focuses on 2 objectives: determining the feasibility of a multi-institutional prospective study in this group of malignancies and obtaining preliminary data on outcomes after postoperative
chemoradiation therapy compared to radiation therapy alone. This study also provides the unique opportunity to collect tissue specimens for future translational investigation, and to establish a
baseline, cooperative group database to use as a reference for future clinical trials in this disease.
3.1 Conditions for Patient Eligibility
3.1.1 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
* high-grade acinic cell carcinoma or high-grade (>30% solid component) adenoid cystic
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
(email@example.com) or Dr. El-Naggar (firstname.lastname@example.org) to expedite such a review.3.1.2 Surgical resection with curative intent within 8 weeks prior to registration;
3.1.3 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:
18.104.22.168 History/physical examination within 8 weeks prior to registration;
22.214.171.124 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.
3.1.4 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 defined as follows:
126.96.36.199 Absolute neutrophil count (ANC) >= 1,800 cells/mm3;
188.8.131.52 Platelets >= 100,000 cells/mm3;
184.108.40.206 Hemoglobin >= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb >=
8.0 g/dl is acceptable.)
3.1.7 Adequate renal and hepatic function within 4 weeks prior to registration;, defined as follows:
220.127.116.11 Serum creatinine < 2.0 mg/dl;
18.104.22.168 Total bilirubin < 2 x the institutional ULN;
22.214.171.124 AST or ALT < 3 x the institutional ULN.
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.
3.1.11 Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for central review.