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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to 5 years.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to 5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to 5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to 5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS), defined by the events of local-regional progression or recurrence, distant metastasis, or death from any cause, primarily at 2 years

Secondary outcome measures

Chemotherapy delivery as measured by percentage of protocol prescription given

Determine whether quality of life, fatigue and xerostomia differ as a function of treatment assignment at 3, 12, and 24 months after completing radiotherapy.

OS rate at 5 years

+5 more

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,901 Total Patients Enrolled

NRG OncologyOTHER

231 Previous Clinical Trials

100,600 Total Patients Enrolled

Radiation Therapy Oncology GroupLead Sponsor

190 Previous Clinical Trials

64,675 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what geographical locations are participants engaging in this research endeavor?

"This trial is pursuing 100 participants and has designated the University of Florida Health Science Center - Jacksonville (Jacksonville), University of Missouri - Ellis Fischel (Columbia), Geisinger Medical Oncology-Lewisburg (Lewisburg) as recruiting sites, alongside other locations."

Answered by AI

What medical conditions usually call for 3-dimensional conformal radiation therapy?

"3-dimensional conformal radiation therapy is usually employed in the treatment of advanced ovarian cancer, however it can be used to treat a wide range of other diseases such as refractory testicular cancers and advance directives."

Answered by AI

What risks and benefits have been documented with 3-dimensional conformal radiation therapy?

"The safety of 3-dimensional conformal radiation therapy was rated as a 2 since data exists to validate its security, yet there is no evidence that attests to its effectiveness."

Answered by AI

Approximately how many participants have joined this trial?

"Currently, this clinical trial is no longer recruiting. It was first advertised on 1st January 2011 and the most recent update to its details were published on 6th April 2022. If you are seeking an alternative study, there are 322 trials actively enrolling patients with head-and-neck cancer and a further 688 studies enlisting participants for 3D conformal radiation therapy research."

Answered by AI

Are there still opportunities for enrolment into this experiment?

"Clinicaltrials.gov indicates that this trial has stopped accepting new enrollees since its last update on April 6th, 2022; however, there are over 1000 other medical studies actively looking to recruit patients at the present moment."

Answered by AI

What have been the findings of past experiments that incorporated 3-dimensional conformal radiation therapy?

"Currently, 688 scientific studies are being conducted for 3-dimensional conformal radiation therapy. Of those trials, 274 have entered Phase 3 and there are 43212 sites conducting them worldwide - the majority of which located in Shanghai."

Answered by AI

Recent research and studies

Current Treatment Options in OncologyJournal

Postoperative Management of Salivary Gland Tumors

Joshi, Nikhil P., and James R. Broughman. 2021. “Postoperative Management of Salivary Gland Tumors”. Current Treatment Options in Oncology. Springer Science and Business Media LLC. doi:10.1007/s11864-021-00820-9.

clinicaltrials.govStudy

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

2011. "Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01220583.