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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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