Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery

• Status: Active, not recruiting
• Trial end date: 2028-10-01
• Target enrollment: 0
• Participant gender: All

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 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/III 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborators: National Cancer Institute (NCI); NRG Oncology
• Treatments: Cisplatin

Criteria

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