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Radiation Therapy

Intensity modulated radiotherapy (IMRT)/volumetric modulated arc therapy (VMAT) or Pencil beam proton therapy (PBPT) for Head and Neck Cancers (SAVER Trial)

Phase 2

Waitlist Available

Led By Matthew Witek, MD

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-years following completion of radiotherapy

Awards & highlights

SAVER Trial Summary

This trial is testing whether reducing the amount of radiation given to the healthy side of the neck reduces the risk of cancer returning in patients with a specific type of throat cancer.

Eligible Conditions

Head and Neck Cancers
Oropharyngeal Cancer
Squamous Cell Carcinoma

SAVER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-years following completion of radiotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-years following completion of radiotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-years following completion of radiotherapy for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Elective out-of-field contralateral nodal failure

Secondary outcome measures

Dysphagia using The M.D. Anderson Dysphagia Inventory (MDADI)

Grade 2/3 xerostomia

Incidence of pulmonary metastases

+4 more

SAVER Trial Design

1Treatment groups

Experimental Treatment

Group I: Reduced C/L elective nodal volumeExperimental Treatment1 Intervention

All patients will receive the reduced C/L elective nodal volume as described. Treatment will be delivered via IMRT/VMAT or PBPT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intensity modulated radiotherapy (IMRT)/volumetric modulated arc therapy (VMAT) or Pencil beam proton therapy (PBPT)

2021

Completed Phase 2

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

687 Previous Clinical Trials

374,594 Total Patients Enrolled

Matthew Witek, MDPrincipal InvestigatorUniversity of Maryland/Maryland Proton Treatment Center

Media Library

Intensity modulated radiotherapy (IMRT)/volumetric modulated arc therapy (VMAT) (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04609280 — Phase 2

Head and Neck Cancers Research Study Groups: Reduced C/L elective nodal volume

Head and Neck Cancers Clinical Trial 2023: Intensity modulated radiotherapy (IMRT)/volumetric modulated arc therapy (VMAT) Highlights & Side Effects. Trial Name: NCT04609280 — Phase 2

Intensity modulated radiotherapy (IMRT)/volumetric modulated arc therapy (VMAT) (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04609280 — Phase 2

Frequently Asked Questions

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

Are there numerous research facilities in operation across the nation that are conducting this investigation?

"There are 6 sites enrolling patients for this study currently. The locations of the centres are in Glen Burnie, Columbia and Bel Air as well as other places. If you want to take part in this trial, it would be ideal to choose a location near you to cut down on travel costs and time."

Answered by AI

Are there any risks associated with Intensity modulated radiotherapy (IMRT)/volumetric modulated arc therapy (VMAT) or Pencil beam proton therapy (PBPT)?

"While there is some evidence of safety, as this is only a Phase 2 trial, neither efficacy nor safety has been conclusively demonstrated. IMRT/volumetric modulated arc therapy (VMAT) or Pencil beam proton therapy (PBPT) received a score of 2."

Answered by AI

How many individuals are currently signed up to partake in this clinical trial?

"That is correct, the online information shows that the trial is still enrolling patients. The study was first publicized on March 1st, 2021 and received its most recent update on April 26th, 2022. There are currently 52 openings for participants at 6 different hospitals."

Answered by AI

Are we still able to sign new patients up for this research project?

"This study, which was first posted on March 1st 2021, is currently looking for candidates. The most recent edit to the study was made on April 26th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Selective Avoidance of Nodal VolumEs at Minimal Risk (GCC 20110)

Department of Radiation Oncology 2021. "Selective Avoidance of Nodal VolumEs at Minimal Risk (GCC 20110)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04609280.