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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: Clinical Trial Phase 1 study, sponsored by Jonsson Comprehensive Cancer Center.
NCT03618134 is a Phase 1 study that was terminated before completion, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Data from all cycles of treatment will be combined in the presentation of safety data. AEs will be listed individually by patient.
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 |
Why NCT03618134 stopped before completion
NCT03618134 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT03618134 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03618134's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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