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Radiation + Chemotherapy for Salivary Gland Cancer

Phase 2
Waitlist Available
Led By Cristina P. Rodriguez, MD
Research Sponsored by Radiation Therapy Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be free of distant metastases based on specific diagnostic workup
Surgical resection with curative intent within 8 weeks prior to registration
Must not have
Acquired immune deficiency syndrome (AIDS) based upon current CDC definition
Pre-existing ≥ grade 2 neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial will compare radiation therapy given alone or with chemotherapy to see which works better in treating salivary gland tumors.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Radiation may cause skin irritation, fatigue, dry mouth or difficulty swallowing. Cisplatin can lead to side effects like nausea, kidney problems, hearing loss, low blood counts increasing infection risk and nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has not spread to distant parts of my body.
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I had surgery to remove cancer with the goal of curing it within the last 8 weeks.
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I have a confirmed diagnosis of a malignant salivary gland tumor.
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My cancer is at a specific stage according to my doctor's evaluation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with AIDS according to CDC guidelines.
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I have moderate to severe nerve damage.
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I have significant hearing loss.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm IIExperimental Treatment2 Interventions
Patients undergo 3D-CRT or IMRT as in arm I.
Group II: Arm IExperimental Treatment3 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3-dimensional conformal radiation therapy
2007
Completed Phase 3
~2690
intensity-modulated radiation therapy
2008
Completed Phase 3
~1490
cisplatin
1997
Completed Phase 3
~3290

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,748 Total Patients Enrolled
NRG OncologyOTHER
236 Previous Clinical Trials
102,023 Total Patients Enrolled
Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
64,674 Total Patients Enrolled

Media Library

3-dimensional conformal radiation therapy Clinical Trial Eligibility Overview. Trial Name: NCT01220583 — Phase 2
Head and Neck Cancers Research Study Groups: Arm I, Arm II
Head and Neck Cancers Clinical Trial 2023: 3-dimensional conformal radiation therapy Highlights & Side Effects. Trial Name: NCT01220583 — Phase 2
3-dimensional conformal radiation therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01220583 — Phase 2
~33 spots leftby Oct 2026
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