Basic Trial Information
|Phase II||Biomarker/Laboratory analysis, Treatment||Closed||18 and over||NCI, Other||RTOG 1008|
CDR0000686072, NCI-2013-00370, NCT01220583
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors.
PURPOSE: This randomized phase II trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.
Further Study Information
- 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.
- Compare the acute toxicities of these 2 adjuvant treatments.
- Compare long-term efficacy results at 5 years and late treatment-related adverse events in patients receiving postoperative radiation to those receiving concurrent chemoradiation.
- 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 a Radiation Therapy Oncology Group (RTOG) baseline database for salivary gland malignancies to serve as a resource for future exploration of innovative and/or targeted approaches for this disease.
OUTLINE: This is a multicenter study. Patients are stratified according to histology (high-grade mucoepidermoid carcinoma vs salivary duct carcinoma vs high-grade adenocarcinoma) and nodal status (N0 vs N1-3). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) 5 days a week for 6-6.5 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiotherapy.
- Arm II: Patients undergo 3D-CRT or IMRT as in arm I. Tissue and blood samples may be collected for translational research studies. Patients may complete quality-of-life assessments periodically.
After completion of study treatment, patients are followed up at 3, 6, 9, 12, and 24 months, every 6 months for 2 years, and then annually thereafter.
- Pathologically proven diagnosis of a malignant major salivary gland tumor of the following histologic subtypes:
- High-grade mucoepidermoid 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
- 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
- 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
Trial Lead Organizations/Sponsors
Radiation Therapy Oncology Group
- National Cancer Institute
- NRG Oncology
Cristina P. Rodriguez, Principal Investigator
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Heath B Mackley
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01220583
ClinicalTrials.gov processed this data on April 09, 2015
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