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NCT03529422 · ClinicalTrials.gov registry record · Phase 2
Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN
A Phase 2 study of Oral Cancer and Lip, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 3
- Study locations
NCT03529422: Active Phase 2 study of Oral Cancer and Lip, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT03529422 is a Phase 2 study of Oral Cancer and Lip that is active but no longer recruiting, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 18 participants, below the 212-participant average among 17 other Oral Cancer trials with a reported enrollment target (92% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03529422, a Phase 2 study of Oral Cancer and Lip, is active but no longer recruiting, sponsored by UNC Lineberger Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to investigate other drugs that may be combined with radiation to treat cancer. The study focuses on determining whether a combination of durvalumab with radiation can both improve cure rate and at the same time have less serious side effects. Throughout this document, this investigational drug will be referred to as the "study drug", or named individually (durvalumab). The study drug in this research is referred to as investigational because the U.S. Food and Drug Administration (FDA) has not yet approved itfor the treatment of head and neck cancer. Durvalumab was FDA approved in 2017 for the treatment of certain types of bladder cancer, but has not been approved for use in Head and Neck cancer patients. Durvalumab is an experimental drug that uses the body's immune system to fight the cancer. This study drug is being used in other ongoing clinical trials for other types of cancers. The doctor feels that a patient may experience fewer side effects using this study drug with radiation rather than using cisplatin. The doctor is also investigating whether using this drug can increase the effectiveness of treatment.
Primary Outcome
Disease-free Survival Rate (DFS) defined as the percentage of participants who were disease-free and alive at 3 years, counting the time from day 1 of treatment to time of disease recurrence or death, was calculated based on the Kaplan-Meier method.
Conditions Studied
Interventions
- DRUG Durvalumab
- RADIATION Intensity Modulated Radiotherapy Treatments
Study Locations (3)
Alabama
- University Of Alabama At Birmingham - Birmingham
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
South Carolina
- Medical University of South Carolina - Hollings Cancer Center - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-10-07 |
| Est. Completion | 2026-05-06 |
| Phase | Phase 2 |
What the registry record for NCT03529422 still lists
NCT03529422 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 212-participant average among 17 other Oral Cancer trials with a reported enrollment target (92% lower).
The record links to 4 conditions, with Oral Cancer appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab is the first listed.
NCT03529422 reports a single indexed study location in Alabama, North Carolina, South Carolina.
Frequently Asked Questions
What is clinical trial NCT03529422 about?
NCT03529422 is a clinical study titled "Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN". The purpose of this study is to investigate other drugs that may be combined with radiation to treat cancer. The study focuses on determining whether a combination of durvalumab with radiation can both improve cure rate and at the same time have less serious side effects. Throughout this document, t...
What is the current status of trial NCT03529422?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2019-10-07. Estimated completion is 2026-05-06.
What conditions does trial NCT03529422 study?
This clinical trial studies the following conditions: Oral Cancer, Lip, Larynx, Digestive Organs--Diseases.
What interventions are being tested in trial NCT03529422?
The interventions under investigation include: Durvalumab (DRUG), Intensity Modulated Radiotherapy Treatments (RADIATION).
Who is sponsoring clinical trial NCT03529422?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03529422 being conducted?
This trial has 3 study locations across Alabama, North Carolina, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03529422's enrollment target sits among peer trials
18 18th of 17 the lowest of 17 other Oral Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oral Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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