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NCT00003070 · ClinicalTrials.gov registry record · Phase 3
Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer
A Phase 3 study of Unspecified Childhood Solid Tumor, Protocol Specific and Cardiac Toxicity, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 13
- Enrollment target
- 20
- Study locations
NCT00003070: Completed Phase 3 study of Unspecified Childhood Solid Tumor, Protocol Specific and Cardiac Toxicity, sponsored by Children's Oncology Group.
NCT00003070 is a Phase 3 study of Unspecified Childhood Solid Tumor, Protocol Specific and Cardiac Toxicity that has completed, run by Children's Oncology Group. The registered enrollment target is 13 participants, below the 1,637-participant average among 13 other Unspecified Childhood Solid Tumor, Protocol Specific trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003070, a Phase 3 study of Unspecified Childhood Solid Tumor, Protocol Specific and Cardiac Toxicity, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 13 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as enalapril, may protect normal cells from the toxic effects of chemotherapy. It is not known whether enalapril is more effective than a placebo in treating heart damage in patients who received anthracycline chemotherapy for childhood cancer. PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of enalapril with a placebo in treating heart damage in patients who received anthracycline chemotherapy for childhood cancer.
Primary Outcome
Cardiac functional status (depressed fractional shortening) and quality-of-life, will be assessed at baseline, two and five years into the study.
Conditions Studied
Interventions
- PROCEDURE quality-of-life assessment
- DRUG enalapril maleate
Study Locations (20)
Florida
- Shands Hospital and Clinics, University of Florida - Gainesville
- Sylvester Cancer Center, University of Miami - Miami
- Miami Children's Hospital - Miami
- CCOP - Florida Pediatric - Tampa
California
- University of California San Diego Cancer Center - La Jolla
- Lucile Packard Children's Hospital at Stanford - Palo Alto
- University of California Davis Medical Center - Sacramento
Louisiana
- MBCCOP - LSU Health Sciences Center - New Orleans
- CCOP - Ochsner - New Orleans
- Ochsner Clinic - New Orleans
Alabama
- University of Alabama at Birmingham Comprehensive Cancer Center - Birmingham
- MBCCOP - Gulf Coast - Mobile
Kansas
- University of Kansas Medical Center - Kansas City
- CCOP - Wichita - Wichita
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Connecticut
- Yale Comprehensive Cancer Center - New Haven
District of Columbia
- Walter Reed Army Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2000-09 |
| Est. Completion | 2007-03 |
| Phase | Phase 3 |
What the finished NCT00003070 record still lists
NCT00003070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 1,637-participant average among 13 other Unspecified Childhood Solid Tumor, Protocol Specific trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Unspecified Childhood Solid Tumor, Protocol Specific appearing as the primary indexed condition, and to 2 interventions - of which quality-of-life assessment is the first listed.
NCT00003070 names 20 study sites across 11 states, led by Florida, California, Louisiana.
Frequently Asked Questions
What is clinical trial NCT00003070 about?
NCT00003070 is a clinical study titled "Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as enalapril, may protect normal cells from the toxic effects of chemotherapy. It is not known whether enalapril is more effective than a placebo in tre...
What is the current status of trial NCT00003070?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 13 participants. The study started on 2000-09. Estimated completion is 2007-03.
What conditions does trial NCT00003070 study?
This clinical trial studies the following conditions: Unspecified Childhood Solid Tumor, Protocol Specific, Cardiac Toxicity.
What interventions are being tested in trial NCT00003070?
The interventions under investigation include: quality-of-life assessment (PROCEDURE), enalapril maleate (DRUG).
Who is sponsoring clinical trial NCT00003070?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00003070 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00003070's enrollment target sits among peer trials
13 13th of 13 higher than 1 of 13 other Unspecified Childhood Solid Tumor, Protocol Specific trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Unspecified Childhood Solid Tumor, Protocol Specific 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.
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