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Durvalumab + Radiotherapy for Oral Cancer

Phase 2
Waitlist Available
Led By Siddharth Sheth, DO MPH
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years of age on day of signing informed consent
ECOG Performance Status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is investigating whether adding the experimental drug durvalumab to radiation therapy can improve cure rates and reduce side effects for people with head and neck cancer.

Who is the study for?
Adults over 18 with intermediate-risk head and neck cancer who've had surgery but no prior treatment for the tumor. They must be in good health, have a performance status of 0 or 1, and women must not be pregnant and agree to contraception. People can't join if they're on other cancer treatments, have an allergy to durvalumab, are immunosuppressed, have certain infections like HIV or hepatitis B/C, or autoimmune diseases.Check my eligibility
What is being tested?
The trial is testing whether combining durvalumab (an immune system-boosting drug) with intensity-modulated radiotherapy improves cure rates while causing fewer side effects than traditional treatments for head and neck cancers. Durvalumab isn't yet approved for this type of cancer but has been used in bladder cancer.See study design
What are the potential side effects?
Durvalumab may cause immune-related reactions affecting various organs, infusion reactions similar to allergic responses during administration, fatigue from energy depletion, digestive issues such as diarrhea or nausea, potential blood disorders like anemia or clotting problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is a type of squamous cell carcinoma located in my head or neck.
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I had surgery to remove my cancer completely within the last 8 weeks, and my cancer has features that might make it come back.
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I have not received any treatment for my tumor before its surgical removal.
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I am a male and will use birth control during and 90 days after treatment if my partner can get pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Disease-free Survival Status
Secondary outcome measures
Acute Coryza
Any-grade chronic toxicities of adjuvant durvalumab with radiotherapy
Chronic toxicities of adjuvant durvalumab with radiotherapy
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-label, single-armExperimental Treatment2 Interventions
Durvalumab in combination with intensity modulated radiotherapy (IMRT) treatments
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Intensity Modulated Radiotherapy Treatments
2015
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
348 Previous Clinical Trials
88,153 Total Patients Enrolled
1 Trials studying Oral Cancers
39 Patients Enrolled for Oral Cancers
AstraZenecaIndustry Sponsor
4,243 Previous Clinical Trials
288,525,876 Total Patients Enrolled
1 Trials studying Oral Cancers
39 Patients Enrolled for Oral Cancers
Siddharth Sheth, DO MPHPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
1 Previous Clinical Trials
45 Total Patients Enrolled

Media Library

Intensity Modulated Radiotherapy Treatments Clinical Trial Eligibility Overview. Trial Name: NCT03529422 — Phase 2
Oral Cancers Research Study Groups: Open-label, single-arm
Oral Cancers Clinical Trial 2023: Intensity Modulated Radiotherapy Treatments Highlights & Side Effects. Trial Name: NCT03529422 — Phase 2
Intensity Modulated Radiotherapy Treatments 2023 Treatment Timeline for Medical Study. Trial Name: NCT03529422 — Phase 2

Frequently Asked Questions

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

Is enrollment for this study still open?

"Unfortunately, no more patients can be enrolled in this study. It was originally published on October 7th 2019 and last updated on May 26th 2022. Fortunately, there are still 73 studies recruiting for larynx related issues and 333 trials actively enrolling participants seeking this treatment option."

Answered by AI

Has this medication obtained the necessary regulatory endorsement?

"Based on the existing evidence, our team believes this treatment is moderately safe and thus assigned a score of 2. This is because Phase 2 trials have yielded some safety data but not yet any efficacy results."

Answered by AI

How many individuals are engaged in this clinical research?

"The recruitment period for this trial has ended. It was posted October 7th 2019 and last updated May 26th 2022. If you are looking to join a medical study, there are currently 73 studies enrolling patients with larynx-related conditions and 333 trials recruiting participants for the same treatment as this one."

Answered by AI

What maladies is this procedure commonly utilized to address?

"Unresectable stage III non-small cell lung cancer is frequently treated with this medication, but it can also be beneficial for individuals who have been newly diagnosed with metastatic urothelial carcinoma or need advance directives."

Answered by AI

Are there any previous experiments that have looked at the efficacy of this treatment?

"Initially studied at City of Hope, this treatment has been the subject of 107 completed clinical trials. Presently, 333 active medical studies are taking place with a substantial amount occurring in Chapel Hill, North carolina."

Answered by AI
~0 spots leftby May 2024