Status:
ACTIVE_NOT_RECRUITING
Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
NRG Oncology
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
OBJECTIVES: Primary Phase II * Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors. * Acquire preliminar...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2028
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT01220583
Start Date
January 1 2011
End Date
October 1 2028
Last Update
February 13 2025
Active Locations (268)
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1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
2
The Kirklin Clinic at Acton Road
Birmingham, Alabama, United States, 35243
3
Arizona Breast Cancer Specialists-Gilbert
Gilbert, Arizona, United States, 85297
4
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, United States, 85381