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NCT03618134 · ClinicalTrials.gov registry record · Phase 1
Stereotactic Body Radiation Therapy and Durvalumab With or Without Tremelimumab Before Surgery in Treating Participants With Human Papillomavirus Positive Oropharyngeal Squamous Cell Caner
A Phase 1 study, sponsored by Jonsson Comprehensive Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT03618134 is a Phase 1 study that was terminated before completion, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 19 participants.
The verdict
NCT03618134, a Phase 1 study, was terminated before completion, sponsored by Jonsson Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This phase Ib/II trial studies the side effects and how well stereotactic body radiation therapy and durvalumab with or without tremelimumab before surgery work in treating participants with human papillomavirus positive oropharyngeal squamous cell cancer. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread. Giving stereotactic body radiation therapy and durvalumab with or without tremelimumab before surgery may work better in treating participants with oropharyngeal squamous cell cancer.
Interventions
- OTHER Quality-of-Life Assessment
- BIOLOGICAL Durvalumab
- RADIATION Stereotactic Body Radiation Therapy
- OTHER Questionnaire Administration
- PROCEDURE Modified Radical Neck Dissection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-10-04 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03618134
The ClinicalTrials.gov registry entry for NCT03618134 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jonsson Comprehensive Cancer Center, which has 321 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.
NCT03618134 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03618134 about?
NCT03618134 is a clinical study titled "Stereotactic Body Radiation Therapy and Durvalumab With or Without Tremelimumab Before Surgery in Treating Participants With Human Papillomavirus Positive Oropharyngeal Squamous Cell Caner". This phase Ib/II trial studies the side effects and how well stereotactic body radiation therapy and durvalumab with or without tremelimumab before surgery work in treating participants with human papillomavirus positive oropharyngeal squamous cell cancer. Stereotactic body radiation therapy is a sp...
What is the current status of trial NCT03618134?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2018-10-04. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT03618134?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Durvalumab (BIOLOGICAL), Stereotactic Body Radiation Therapy (RADIATION), Questionnaire Administration (OTHER), Modified Radical Neck Dissection (PROCEDURE).
Who is sponsoring clinical trial NCT03618134?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
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