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RTOG 1008: A RANDOMIZED PHASE II/III STUDY OF ADJUVANT CONCURRENT RADIATION AND CHEMOTHERAPY VERSUS RADIATION ALONE IN RESECTED HIGH-RISK MALIGNANT SALIVARY GLAND TUMORS

Description

Background:Malignant tumors of the salivary gland are rare cancers that represent less than 5% of all newly diagnosed head and neck malignancies. Memorial Sloan Kettering Cancer Center reported treating 1,278 patients for malignant tumors of the salivary gland from 1939 to 1973 and identified the parotid gland followed by the submandibular glands as the most common primary sitesSurgery remains the definitive treatment of choice in patients with salivary gland malignancies without evidence of distant hematogenous metastasis. Outcomes after surgery in early stage disease are excellent. There is little high level clinical evidence to support the use of postoperative radiation. The data are limited to retrospective series that describe improved local control rates compared to surgical resection aloneHigh risk resected salivary gland malignancies represent a clinical scenario with potential for improving outcomes through multimodality therapy.Objectives: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.Description of Study Arms:Arm 1: Radiation: 60-66 Gy in 2 Gy daily fractions Cisplatin: 40 mg/m weekly during radiation for 7 dosesArm 2: Radiation: 60-66 Gy in 2 Gy daily fractionsEndpoints:The primary endpoint is progression-free survival (PFS), defined by the events of local-regional progression or recurrence, distant metastasis, or death from any cause. Primary interest will focus on 2-year PFS because the recurrence/failure rate is highest during this time interval, so as to expedite the design of subsequent clinical trials in this disease.Follow-up:Follow-up: 3 months following radiation therapy. Then at months 6, 9, 12, 18, and 24 from the start of radiation for years 1 and 2, every 6 months for years 3 and 4, and then yearly for the lifetime of the subject.Statistics/Analysis:The principal comparison will be between the 2 protocol arms, since there is no prospective cooperative group experience using post-operative adjuvant radiation therapy alone in patients with resected high-risk malignant salivary gland tumors. The PFS rates for each regimen will be directly compared.

Phase

Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion Criteria

  • 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 acinic cell carcinoma or high-grade (>30% solid component) adenoid cystic carcinoma
  • 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 prior systemic chemotherapy or radiation therapy for salivary gland malignancy 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

Sites

  • California

    • UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, 94115
  • Idaho

    • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center, Boise, Idaho, 83706
  • Colorado

    • Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, 80933
    • Swedish Medical Center, Englewood, Colorado, 80110
    • Porter Adventist Hospital, Denver, Colorado, 80210
    • North Suburban Medical Center, Thornton, Colorado, 80229
    • Rocky Mountain Cancer Centers - Aurora, Aurora, Colorado, 80012
    • McKee Medical Center, Loveland, Colorado, 80539
  • Oregon

    • Clackamas Radiation Oncology Center, Clackamas, Oregon, 97015
    • Providence St. Vincent Medical Center, Portland, Oregon, 97225
  • Washington

    • Northwest Cancer Specialists at Vancouver Cancer Center, Vancouver, Washington, 98684
  • South Dakota

    • Rapid City Regional Hospital, Rapid City, South Dakota, 57701
  • Oklahoma

    • Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, 73104
  • Texas

    • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, 75390
  • Nebraska

    • Methodist Estabrook Cancer Center, Omaha, Nebraska, 68114
  • Iowa

    • Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, 51101
    • John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, 50309
    • McFarland Clinic, PC, Ames, Iowa, 50010
  • Louisiana

    • Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge, Louisiana, 70809
  • Illinois

    • Cancer Institute at St. John's Hospital, Springfield, Illinois, 62702
  • Mississippi

    • University of Mississippi Cancer Clinic, Jackson, Mississippi, 39216
  • Wisconsin

    • Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, 53226
    • St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, 54303
    • Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, 54143
  • Kentucky

    • James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky, 40202
  • Indiana

    • Center for Cancer Care at Goshen General Hospital, Goshen, Indiana, 46526
  • Ohio

    • Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, 45267
    • Precision Radiotherapy at University Pointe, West Chester, Ohio, 45069
  • Georgia

    • Winship Cancer Institute of Emory University, Atlanta, Georgia, 30322
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