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NCT03258554 · ClinicalTrials.gov registry record · Phase 2
Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 196
- Enrollment target
NCT03258554: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT03258554 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 196 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03258554, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 196 participants
- Enrollment target
Study Summary
This phase II/III trial studies how well radiation therapy works with durvalumab or cetuximab in treating patients with head and neck cancer that has spread to a local and/or regional area of the body who cannot take cisplatin. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. It is not known if radiation therapy with durvalumab will work better than the usual therapy of radiation therapy with cetuximab in treating patients with head and neck cancer.
Primary Outcome
DLTs were collected to verify the safety of durvalumab with RT in this population. Safety was determined if ≤ 2 of 8 participants in the cohort had any DLT, in which case the study would proceed to phase II with that dose schedule (DS). The probability for the DS to be deemed too toxic, given a true toxicity rate ≥ 45%, is at least 78%. With a true toxicity rate ≤ 20%, the probability for the DS do be deemed safe is 80%. The full DLT definition does not fit here, but includes all grade 5 AEs, gr
Interventions
- OTHER Quality-of-Life Assessment
- BIOLOGICAL Cetuximab
- BIOLOGICAL Durvalumab
- OTHER Laboratory Biomarker Analysis
- RADIATION Intensity-Modulated Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2018-04-03 |
| Est. Completion | 2025-09-04 |
| Phase | Phase 2 |
What the finished NCT03258554 record still lists
NCT03258554 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT03258554 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03258554 about?
NCT03258554 is a clinical study titled "Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin". This phase II/III trial studies how well radiation therapy works with durvalumab or cetuximab in treating patients with head and neck cancer that has spread to a local and/or regional area of the body who cannot take cisplatin. Radiation therapy uses high energy x-rays to kill tumor cells and shrink...
What is the current status of trial NCT03258554?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 196 participants. The study started on 2018-04-03. Estimated completion is 2025-09-04.
What interventions are being tested in trial NCT03258554?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Cetuximab (BIOLOGICAL), Durvalumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Intensity-Modulated Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT03258554?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03258554's enrollment target sits among peer trials
196 349th of 2000 higher than 1,651 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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