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Radiation Therapy

Radiotherapy for Throat Cancer (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
No Placebo-Only Group

Summary

This trial tests a new radiation therapy method for patients with a specific type of throat cancer. It aims to reduce side effects by focusing radiation only on high-risk areas, potentially lowering issues like dry mouth and swallowing difficulties.

Who is the study for?
This trial is for adults with p16 positive oropharyngeal squamous cell carcinoma needing radiotherapy. They must have a good performance status, no prior invasive malignancies within 3 years (except skin cancer), and agree to use contraception if applicable. Pregnant/nursing individuals, those with certain head/neck surgeries, previous chemotherapy/radiotherapy for the study cancer, or evidence of contralateral nodal disease are excluded.
What is being tested?
The trial tests whether reducing radiation treatment volumes on one side of the neck can prevent cancer recurrence in patients undergoing definitive or adjuvant radiotherapy. It compares Intensity Modulated Radiotherapy (IMRT)/Volumetric Modulated Arc Therapy (VMAT) against Pencil Beam Proton Therapy (PBPT).
What are the potential side effects?
Potential side effects include typical reactions to radiation therapy such as skin irritation at the treatment site, dry mouth, difficulty swallowing, taste changes, fatigue and in rare cases more severe complications like damage to surrounding tissues.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Elective out-of-field contralateral nodal failure
Secondary study objectives
Dysphagia using The M.D. Anderson Dysphagia Inventory (MDADI)
Grade 2/3 xerostomia
PEG-tube rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,440 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
Oropharyngeal Cancer Research Study Groups: Reduced C/L elective nodal volume
Oropharyngeal Cancer 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
~18 spots leftby Dec 2026
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