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Clinical Trial 18612

Cancer Type: Head & Neck
Interventions:cisplatin ()

Study Type: Treatment
Phase of Study: Phase II/III
Investigators:

  • Jimmy Caudell

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

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

Summary

The purpose of this study is to test whether the use of chemotherapy with radiation will improve the results compared to surgery and radiation alone.

Objective

NOTE: Phase II is complete. Phase II: 1. Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors; 2. Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin. Phase III: 1. Compare overall survival rates among patients receiving cisplatin and radiation to those receiving radiation alone. Phase II/III Secondary Objectives: 1. Compare the acute toxicities of these 2 adjuvant treatments; 2. Compare late treatment-related adverse events in patients receiving postoperativeradiation to those receiving concurrent chemoradiation; 3. 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). 4. Investigate quality of life and patient-reported outcomes in patients enrolled in the study; 5. Identify the histopathology and tumor marker expression from patients enrolled on this trial and assemble a tissue bank for future correlative studies; 6. 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.

Inclusion Criteria

  • Age 18 years or older
  • 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
  • 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; must be free of distant metastases based upon diagnostic workup: 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
  • Adequate bone marrow function
  • Adequate renal and hepatic function
  • 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
  • Must be deemed able to comply with the treatment plan and follow-up schedule
  • Must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for central review
  • Additional criteria may apply

    • Exclusion Criteria

  • Residual macroscopic disease after surgery
  • Salivary gland malignancies originating from the minor salivary glands
  • Histologies other than high-grade mucoepidermoid carcinoma, high-grade adenocarcinoma, or salivary duct carcinoma
  • Women who are pregnant or nursing
  • 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)
  • Severe, active co-morbidity
  • Significant pre-existing hearing loss, as defined by the patient or treating physician
  • Prior systemic chemotherapy or radiation therapy for salivary gland malignancy (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
  • Prior organ transplant
  • Concurrent hematopoietic growth factors (e.g., G-CSF or pegfilgrastim) during radiotherapy
  • Concurrent erythropoiesis-stimulating agents
  • Additional criteria may apply

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