🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Canada / NCT01220583
Active, not recruiting Phase 2

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

NCT01220583 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2011-01
Last updated
2026-05-27

Condition(s) studied

Head and Neck Cancer

Investigational drug(s) / intervention(s)

cisplatin →3-dimensional conformal radiation therapyintensity-modulated radiation therapy

cisplatin: Given IV

3-dimensional conformal radiation therapy: Undergo radiotherapy

intensity-modulated radiation therapy: Undergo radiotherapy

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (268)

FacilityCityRegionStatus
University of Alabama at Birmingham Cancer Center Birmingham Alabama
The Kirklin Clinic at Acton Road Birmingham Alabama
Arizona Breast Cancer Specialists-Gilbert Gilbert Arizona
Arizona Center for Cancer Care-Peoria Peoria Arizona
Cancer Center at Saint Joseph's Phoenix Arizona
Arizona Breast Cancer Specialists-Phoenix Phoenix Arizona
Arizona Oncology-Deer Valley Center Phoenix Arizona
Arizona Breast Cancer Specialists Scottsdale Arizona
Arizona Breast Cancer Specialists-Scottsdale Scottsdale Arizona
Arizona Oncology Services Foundation Scottsdale Arizona
Arizona Center for Cancer Care-Surprise Surprise Arizona
University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona
Banner University Medical Center - Tucson Tucson Arizona
University of Arizona Cancer Center-North Campus Tucson Arizona
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
AIS Cancer Center at San Joaquin Community Hospital Bakersfield California
Mills-Peninsula Medical Center Burlingame California
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California
Mercy San Juan Medical Center Carmichael California
City of Hope Comprehensive Cancer Center Duarte California
UC San Diego Moores Cancer Center La Jolla California
Los Angeles County-USC Medical Center Los Angeles California
USC / Norris Comprehensive Cancer Center Los Angeles California
Fremont - Rideout Cancer Center Marysville California
Memorial Medical Center Modesto California
Hoag Memorial Hospital Newport Beach California
Saint Joseph Hospital - Orange Orange California
Stanford Cancer Institute Palo Alto Palo Alto California
Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California
Sutter Medical Center Sacramento Sacramento California
University of California Davis Comprehensive Cancer Center Sacramento California
UCSF Medical Center-Mount Zion San Francisco California
UCSF Medical Center-Mission Bay San Francisco California
Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville California
Rocky Mountain Cancer Centers-Aurora Aurora Colorado
University of Colorado Hospital Aurora Colorado
Boulder Community Hospital Boulder Colorado
Penrose-Saint Francis Healthcare Colorado Springs Colorado
Porter Adventist Hospital Denver Colorado
Swedish Medical Center Englewood Colorado

+ 228 more sites — see the full list on the official registry below.

More Radiation Therapy Oncology Group trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01220583 on ClinicalTrials.gov ↗ ← All trials in Canada