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NCT03818776 · ClinicalTrials.gov registry record · Early Phase 1
Proton Based Cardiac Sparing Accelerated Fractionated RadioTherapy in Unresectable NSCLC
A Early Phase 1 study, sponsored by Case Comprehensive Cancer Center.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 7
- Enrollment target
NCT03818776: Clinical Trial Early Phase 1 study, sponsored by Case Comprehensive Cancer Center.
NCT03818776 is a Early Phase 1 study that was terminated before completion, run by Case Comprehensive Cancer Center. The registered enrollment target is 7 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03818776, a Early Phase 1 study, was terminated before completion, sponsored by Case Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
The purpose of this study is to treat participants with the combination of durvalumab (the study drug) and proton beam therapy. Proton beam therapy is a type of radiotherapy (RT) with a unique characteristic where the proton stops at a specific depth according to its energy. This may be advantageous in treating lung cancer because it allows for a sufficient tumor dose that may improve local control and survival while sparing normal organs at risk, such as the heart, lung, and spinal cord.
Primary Outcome
Safety of intervention as defined by number of participants with DLT's between first dose of Durvalumab and 30 days following completion of radiotherapy. This is defined as 0 of 3 or 1 of 6 participants having no DLT of either Durvalumab or RT. DLT for RT defined as: 1. Grade 4-5 non-hematologic serious adverse events (SAEs) considered by the Investigators to be probably or definitely related to protocol treatment. 2. Grade 3 or higher cardiac adverse events (e.g. severely symptomatic congesti
Interventions
- DRUG Durvalumab
- RADIATION Proton beam therapy RT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-08-30 |
| Est. Completion | 2022-01-27 |
| Phase | Early Phase 1 |
Why NCT03818776 stopped before completion
NCT03818776 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Durvalumab is the first listed.
NCT03818776 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03818776 about?
NCT03818776 is a clinical study titled "Proton Based Cardiac Sparing Accelerated Fractionated RadioTherapy in Unresectable NSCLC". The purpose of this study is to treat participants with the combination of durvalumab (the study drug) and proton beam therapy. Proton beam therapy is a type of radiotherapy (RT) with a unique characteristic where the proton stops at a specific depth according to its energy. This may be advantageous...
What is the current status of trial NCT03818776?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 7 participants. The study started on 2019-08-30. Estimated completion is 2022-01-27.
What interventions are being tested in trial NCT03818776?
The interventions under investigation include: Durvalumab (DRUG), Proton beam therapy RT (RADIATION).
Who is sponsoring clinical trial NCT03818776?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03818776's enrollment target sits among peer trials
7 1825th of 2000 higher than 156 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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