Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery
NCT01220583 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 252
Last updated 2025-02-13
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.
Conditions
Interventions
- DRUG
-
Given IV
- RADIATION
-
3-dimensional conformal radiation therapy
Undergo radiotherapy
- RADIATION
-
intensity-modulated radiation therapy
Undergo radiotherapy
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
NRG Oncology
collaborator OTHER -
Radiation Therapy Oncology Group
lead NETWORK
Principal Investigators
-
Cristina P. Rodriguez, MD · OHSU Knight Cancer Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-01-31
- Primary Completion
- 2026-10-31
- Completion
- 2028-10-31
Countries
- United States
- Canada
- Saudi Arabia
Study Locations
More Related Trials
-
L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer
NCT01155609 ·Status: COMPLETED ·Phase: NA
-
Parotid-gland Stem-cell Sparing Intensity-modulated Radiotherapy
NCT01955239 ·Status: COMPLETED ·Phase: NA
-
Submandibular Gland Stem Cell Transplantation
NCT04593589 ·Status: RECRUITING ·Phase: PHASE1
-
Effect of AdhAQP1 on Salivary Flow in Patients Treated With Radiation for Head and Neck Cancer
NCT00372320 ·Status: COMPLETED ·Phase: PHASE1
-
A Pilot Study to Evaluate the Feasibility of Combining Submandibular Salivary Gland Tx & IMRT Tomo to Reduce Xerostomia
NCT00497406 ·Status: UNKNOWN ·Phase: NA
-
Trial Comparing Oral Pilocarpine (Salagen) Versus Submandibular Salivary Gland Transfer Protocol, For the Prevention of Radiation (XRT) Induced Xerostomia in Head and Neck Cancer Patients
NCT00168181 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Novel Edible Gel-based Artificial Saliva in Cancer Patients
NCT01885065 ·Status: COMPLETED ·Phase: NA
-
Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy
NCT02123511 ·Status: COMPLETED ·Phase: PHASE2
-
Everolimus in Restoring Salivary Gland Function in Participants With Locally Advanced Head and Neck Cancer Treated With Radiation Therapy
NCT03578432 ·Status: TERMINATED ·Phase: EARLY_PHASE1
-
Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia
NCT00081029 ·Status: UNKNOWN ·Phase: PHASE3
-
Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy
NCT01682031 ·Status: TERMINATED ·Phase: PHASE2
-
Functional Sparing of Salivary Glands Using MRI Sialography for Patients Undergoing Definitive Radiation Therapy for Head and Neck Cancers of the Oropharynx
NCT03418792 ·Status: COMPLETED ·Phase: NA
-
Cross-Sectional Study of Oral Health in Patients After Parotid-Sparing Radiation Therapy for Head and Neck Cancer
NCT01663246 ·Status: COMPLETED ·Phase: NA
-
Dietary Nitrate on Salivary Flow for Nasopharyngeal Carcinoma Patients
NCT02854410 ·Status: UNKNOWN ·Phase: NA
-
Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract
NCT01548846 ·Status: TERMINATED ·Phase: PHASE2
-
Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia
NCT00503776 ·Status: TERMINATED ·Phase: PHASE2
-
Intravenous Versus Subcutaneous Amifostine in Prevention of Xerostomia After RT for Head and Neck Carcinomas
NCT00158691 ·Status: COMPLETED ·Phase: PHASE3
-
Sargramostim to Prevent Mucositis in Patients Receiving Radiation Therapy for Laryngeal Cancer
NCT00004256 ·Status: COMPLETED ·Phase: PHASE2
-
Impact on Xerostomia for Nasopharyngeal Carcinoma Patients Treated With or Without Superficial Parotid Lobe-sparing Intensity-modulated Radiotherapy
NCT05020067 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of Treatment Related Toxicity After Radiotherapy for Head and Neck Cancer
NCT01621048 ·Status: WITHDRAWN
-
Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer
NCT06532279 ·Status: RECRUITING ·Phase: PHASE2
-
Amifostine With IMRT for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment
NCT00409331 ·Status: TERMINATED ·Phase: PHASE2
-
Oropharyngeal Function After Radiotherapy With IMRT
NCT00506324 ·Status: TERMINATED
-
A Research About Nutrition Impact for Local Advanced Nasopharyngeal Carcinoma Patients
NCT02948699 ·Status: UNKNOWN ·Phase: PHASE4
-
The Effectiveness of a Thyme and Honey Spray for Oral Toxicities
NCT04880148 ·Status: UNKNOWN ·Phase: NA