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Clinical Trial ECOGTHNR1008

Title

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

Principal Investigator(s)

Kenneth Niermann

Details

  • Protocol No. ECOGTHNR1008
  • Open Date: 09/07/2012
  • Staging: Phase II
  • Age Group: Adults
  • Scope: National
  • Objective: 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.
  • Disease Sites: Head/Neck
  • Therapies: Chemotherapy - cytotoxic; Radiotherapy
  • Drugs: Cisplatin
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01220583
  • Secondary Protocol No: RTOG-1008 (site# 357)

Description

The standard treatment for cancer of the salivary gland is surgery, and all patients will have had surgery before taking part in this study. Although the surgery may have removed the cancer, features of the disease suggest that these participants are at an increased risk for their cancer to return. In patients at risk for disease recurrence after surgery, radiation therapy to the head and neck is often recommended after surgery. The purpose of this study is to test whether the use of chemotherapy with radiation will improve the results when compared to surgery and radiation alone. The study will compare the effects, good and/or bad, of radiation and chemotherapy or radiation alone on salivary gland cancer to find out which is better at reducing the chance that their cancer will come back. About 120 people will take part in this study; about 3 of them will be at Vanderbilt.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

DISEASE CHARACTERISTICS:
• 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 within 8 weeks prior to registration
• All patients must have a Medical Oncology evaluation within 4 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:
• 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)
• No patients with residual macroscopic disease after surgery
• No patients with salivary gland malignancies originating from the minor salivary glands
• No patients with histologies other than high-grade mucoepidermoid carcinoma, high-grade adenocarcinoma, or salivary duct carcinoma
PATIENT CHARACTERISTICS:
• Zubrod performance status 0-1
• Absolute neutrophil count (ANC) ≥ 1,800 cells/mm^3
• Platelets ≥ 100,000 cells/mm^3
• Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL is acceptable)
• Serum creatinine < 2.0 mg/dL
• Total bilirubin < 2 x the institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) or alanine aminotransferase (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
• Not pregnant or nursing
• 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
• No 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)
• No 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 (coagulation parameters are not required for entry into this protocol)
• Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition (HIV testing is not required for entry into this protocol)
• Protocol-specific requirements may also exclude immunocompromised patients
• Pre-existing ≥ grade 2 neuropathy
• No significant pre-existing hearing loss, as defined by the patient or treating physician
PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• No prior systemic chemotherapy or radiation therapy for salivary gland malignancy (prior chemotherapy for a different cancer is allowable)
• No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• No prior organ transplant
• No concurrent hematopoietic growth factors (e.g., G-CSF or pegfilgrastim) during radiotherapy
• No concurrent erythropoiesis-stimulating agents