Radiation + Chemotherapy for Salivary Gland Cancer

Recruiting at301 trial locations

Overseen by Cristina P. Rodriguez, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Radiation Therapy Oncology Group

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Cristina P. Rodriguez, MD

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

This trial is for patients with high-risk malignant salivary gland tumors removed by surgery. Eligible participants must have certain types of these tumors, no macroscopic disease post-surgery, and be free of distant metastases. They should not have had prior chemo or radiation for this cancer and must meet specific blood count and organ function criteria.

Inclusion Criteria

I had surgery to remove cancer with the goal of curing it within the last 8 weeks.

Patients must meet specific patient characteristics criteria

My cancer has not spread to distant parts of my body.

Exclusion Criteria

Severe, active co-morbidities as defined

Immunocompromised patients

Prior concurrent therapy restrictions

Treatment Details

Interventions

• 3-dimensional conformal radiation therapy (Radiation)
• Cisplatin (Alkylating agents)
• Intensity-modulated radiation therapy (Radiation)

Trial Overview The study is examining the effectiveness of radiation therapy alone versus combined with chemotherapy (cisplatin) in treating patients after surgical removal of salivary gland tumors. It's a randomized trial, meaning patients are randomly assigned to one treatment or the other.

Participant Groups

Group I: Arm II Experimental Treatment 2 Interventions

Patients undergo 3D-CRT or IMRT as in arm I.

Group II: Arm I Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

Radiation Therapy Oncology Group

Lead Sponsor

Trials

191

Recruited

64,900+

Dr. Vivek S. Kavadi

Radiation Therapy Oncology Group

Chief Executive Officer

MD from Harvard Medical School, MBA from The Wharton School

Dr. Gita Suneja

Radiation Therapy Oncology Group

Chief Medical Officer

MD from University of Utah School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School