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Birinapant and Intensity Modulated Re-Irradiation Therapy in Treating Patients With Locally Recurrent Head and Neck Squamous Cell Carcinoma
NCT03803774 · View on ClinicalTrials.gov ↗
Study Summary
This phase I trial studies the side effects and best dose of birinapant when given together with intensity modulated re-irradiation therapy (IMRRT) in treating patients with head and neck squamous cell carcinoma that has come back at or near the same place as the original (primary) tumor (locally recurrent). Birinapant may stop the growth of tumor cells by blocking inhibitor of apoptosis (IAP), a protein needed for tumor cell survival. IMRRT uses thin beams of radiation of different intensities that are aimed at the tumor from many angles. This type of re-irradiation therapy reduces the damage to healthy tissue near the tumor. Giving birinapant with IMRRT may lower the chance of head and neck squamous cell carcinoma growing or spreading.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Biopsy Procedure
- RADIATION Intensity-Modulated Radiation Therapy
- DRUG Birinapant
Study Locations (20)
Kansas
- University of Kansas Clinical Research Center — Fairway
- HaysMed — Hays
- University of Kansas Cancer Center — Kansas City
- Lawrence Memorial Hospital — Lawrence
- The University of Kansas Cancer Center - Olathe — Olathe
- University of Kansas Cancer Center-Overland Park — Overland Park
- Mercy Hospital Pittsburg — Pittsburg
- Salina Regional Health Center — Salina
- University of Kansas Health System Saint Francis Campus — Topeka
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami
- UM Sylvester Comprehensive Cancer Center at Plantation — Plantation
- Moffitt Cancer Center-International Plaza — Tampa
- Moffitt Cancer Center - McKinley Campus — Tampa
- Moffitt Cancer Center — Tampa
California
- Los Angeles General Medical Center — Los Angeles
- USC / Norris Comprehensive Cancer Center — Los Angeles
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange
Alabama
- University of Alabama at Birmingham Cancer Center — Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-09-25 |
| Est. Completion | 2026-07-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03803774
The ClinicalTrials.gov registry entry for NCT03803774 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Locally Recurrent Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which Computed Tomography is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03803774 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Kansas, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03803774 about?
NCT03803774 is a clinical study titled "Birinapant and Intensity Modulated Re-Irradiation Therapy in Treating Patients With Locally Recurrent Head and Neck Squamous Cell Carcinoma". This phase I trial studies the side effects and best dose of birinapant when given together with intensity modulated re-irradiation therapy (IMRRT) in treating patients with head and neck squamous cell carcinoma that has come back at or near the same place as the original (primary) tumor (locally re...
What is the current status of trial NCT03803774?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2019-09-25. Estimated completion is 2026-07-09.
What conditions does trial NCT03803774 study?
This clinical trial studies the following conditions: Locally Recurrent Head and Neck Squamous Cell Carcinoma, Sinonasal Squamous Cell Carcinoma, Nasopharyngeal Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03803774?
The interventions under investigation include: Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Intensity-Modulated Radiation Therapy (RADIATION), Birinapant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03803774?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03803774 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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