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NCT00077064 · ClinicalTrials.gov registry record · Phase 2
Captopril in Treating Patients With Non-Small Cell Lung Cancer or Limited-Stage Small Cell Lung Cancer That Has Been Previously Treated With Radiation Therapy With or Without Chemotherapy
A Phase 2 study, sponsored by Radiation Therapy Oncology Group.
- Terminated
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
NCT00077064: Clinical Trial Phase 2 study, sponsored by Radiation Therapy Oncology Group.
NCT00077064 is a Phase 2 study that was terminated before completion, run by Radiation Therapy Oncology Group. The registered enrollment target is 81 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00077064, a Phase 2 study, was terminated before completion, sponsored by Radiation Therapy Oncology Group.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
Study Summary
RATIONALE: Captopril is a drug that may be able to decrease side effects caused by radiation therapy, and may improve the quality of life of patients with non-small cell lung cancer or limited-stage small cell lung cancer. PURPOSE: This randomized phase II trial is studying how well captopril works in decreasing side effects and improving the quality of life in patients who have received radiation therapy with or without chemotherapy for stage I, stage II, or stage IIIB non-small cell lung cancer or limited-stage small cell lung cancer.
Primary Outcome
Incidence of Grade 2+ radiation-induced pulmonary toxicity within 1 year after completion of radiation. Assuming that the incidence of pulmonary toxicity would be 50%, based on Fisher's exact test with a one-sided significance level of 0.05,168 randomized patients would be required to have 80% statistical power to detect a 40% relative reduction (from 50% to 30%) in the incidence of pulmonary toxicity while receiving captopril. Assuming that 15% of cases would not continue to the randomization s
Interventions
- DRUG captopril
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2003-06 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
Why NCT00077064 stopped before completion
NCT00077064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 1 intervention - of which captopril is the first listed.
NCT00077064 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00077064 about?
NCT00077064 is a clinical study titled "Captopril in Treating Patients With Non-Small Cell Lung Cancer or Limited-Stage Small Cell Lung Cancer That Has Been Previously Treated With Radiation Therapy With or Without Chemotherapy". RATIONALE: Captopril is a drug that may be able to decrease side effects caused by radiation therapy, and may improve the quality of life of patients with non-small cell lung cancer or limited-stage small cell lung cancer. PURPOSE: This randomized phase II trial is studying how well captopril works...
What is the current status of trial NCT00077064?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2003-06. Estimated completion is 2016-12.
What interventions are being tested in trial NCT00077064?
The interventions under investigation include: captopril (DRUG).
Who is sponsoring clinical trial NCT00077064?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00077064's enrollment target sits among peer trials
81 834th of 2000 higher than 1,159 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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