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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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • OTHER Quality-of-Life Assessment
  • BIOLOGICAL Cetuximab
  • BIOLOGICAL Durvalumab
  • OTHER Laboratory Biomarker Analysis
  • RADIATION Intensity-Modulated Radiation Therapy

Trial Details

FieldValue
Enrollment Target 196 participants
Start Date 2018-04-03
Est. Completion 2025-09-04
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT03258554

The ClinicalTrials.gov registry entry for NCT03258554 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 196 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 3,257 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.

NCT03258554 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.