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NCT00002610 · ClinicalTrials.gov registry record · Phase 3
Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors
A Phase 3 study of Kidney Cancer, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 203
- Enrollment target
- 20
- Study locations
NCT00002610: Completed Phase 3 study of Kidney Cancer, sponsored by Children's Oncology Group.
NCT00002610 is a Phase 3 study of Kidney Cancer that has completed, run by Children's Oncology Group. The registered enrollment target is 203 participants, below the 877-participant average among 60 other Kidney Cancer trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00002610, a Phase 3 study of Kidney Cancer, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 203 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which therapy regimen is most effective for treating patients with kidney tumors. PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy, surgery, and/or peripheral stem cell or bone marrow transplantation in treating young patients with kidney tumors.
Primary Outcome
To determine the two-year second event-free survival percentage for children who relapse following initial therapy with nephrectomy only following treatment with vincristine and dactinomycin, with or without doxorubicin, depending upon the site of relapse and presence or absence of microscopic residual disease.
Conditions Studied
Interventions
- DRUG carboplatin
- DRUG cyclophosphamide
- BIOLOGICAL filgrastim
- DRUG doxorubicin hydrochloride
- BIOLOGICAL dactinomycin
Study Locations (20)
California
- Southern California Permanente Medical Group - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- Rebecca and John Moores UCSD Cancer Center - La Jolla
- Loma Linda University Medical Center - Loma Linda
- Jonathan Jaques Children's Cancer Center - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- Jonsson Comprehensive Cancer Center, UCLA - Los Angeles
- Children's Hospital Central California - Madera
- Children's Hospital of Oakland - Oakland
- Chao Family Comprehensive Cancer Center - Orange
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital at Stanford - Palo Alto
- Sutter Cancer Center - Sacramento
- University of California Davis Medical Center - Sacramento
Alabama
- University of Alabama at Birmingham Comprehensive Cancer Center - Birmingham
- University of South Alabama Medical Center - Mobile
Arizona
- Phoenix Children's Hospital - Phoenix
- Arizona Cancer Center - Tucson
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 1996-01 |
| Est. Completion | 2006-02 |
| Phase | Phase 3 |
What the finished NCT00002610 record still lists
NCT00002610 is an interventional study that assigns participants to a tested intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap, below the 877-participant average among 60 other Kidney Cancer trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Kidney Cancer appearing as the primary indexed condition, and to 5 interventions - of which carboplatin is the first listed.
NCT00002610 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00002610 about?
NCT00002610 is a clinical study titled "Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemo...
What is the current status of trial NCT00002610?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 203 participants. The study started on 1996-01. Estimated completion is 2006-02.
What conditions does trial NCT00002610 study?
This clinical trial studies the following conditions: Kidney Cancer.
What interventions are being tested in trial NCT00002610?
The interventions under investigation include: carboplatin (DRUG), cyclophosphamide (DRUG), filgrastim (BIOLOGICAL), doxorubicin hydrochloride (DRUG), dactinomycin (BIOLOGICAL).
Who is sponsoring clinical trial NCT00002610?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00002610 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00002610's enrollment target sits among peer trials
203 16th of 60 higher than 45 of 60 other Kidney Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Cancer 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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