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NCT00945009 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor
A Phase 3 study of Stage III Kidney Wilms Tumor and Rhabdoid Tumor of the Kidney, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 3
- Development phase
- 249
- Enrollment target
- 20
- Study locations
NCT00945009: Active Phase 3 study of Stage III Kidney Wilms Tumor and Rhabdoid Tumor of the Kidney, sponsored by Children's Oncology Group.
NCT00945009 is a Phase 3 study of Stage III Kidney Wilms Tumor and Rhabdoid Tumor of the Kidney that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 249 participants, below the 486-participant average among 3 other Stage III Kidney Wilms Tumor trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00945009, a Phase 3 study of Stage III Kidney Wilms Tumor and Rhabdoid Tumor of the Kidney, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 249 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial studies how well combination chemotherapy and surgery work in treating young patients with Wilms tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.
Primary Outcome
Probability of no relapse, secondary malignancy, or death whichever occurs first
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- DRUG Doxorubicin Hydrochloride
- PROCEDURE Therapeutic Conventional Surgery
- BIOLOGICAL Dactinomycin
- DRUG Vincristine Sulfate
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- University of California Davis Comprehensive Cancer Center - Sacramento
- Rady Children's Hospital - San Diego - San Diego
- UCSF Medical Center-Parnassus - San Francisco
- UCSF Medical Center-Mission Bay - San Francisco
Alabama
- Children's Hospital of Alabama - Birmingham
- University of Alabama at Birmingham Cancer Center - Birmingham
Arizona
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Arkansas
- Arkansas Children's Hospital - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 249 participants |
| Start Date | 2009-07-13 |
| Phase | Phase 3 |
What the registry record for NCT00945009 still lists
NCT00945009 is an interventional study that assigns participants to a tested intervention. The registered 249 participants enrollment target is mid-sized for trials with a published cap, below the 486-participant average among 3 other Stage III Kidney Wilms Tumor trials with a reported enrollment target (49% lower).
The record links to 10 conditions, with Stage III Kidney Wilms Tumor appearing as the primary indexed condition, and to 5 interventions - of which Radiation Therapy is the first listed.
NCT00945009 names 20 study sites across 5 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00945009 about?
NCT00945009 is a clinical study titled "Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor". This phase III trial studies how well combination chemotherapy and surgery work in treating young patients with Wilms tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spre...
What is the current status of trial NCT00945009?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 249 participants. The study started on 2009-07-13.
What conditions does trial NCT00945009 study?
This clinical trial studies the following conditions: Stage III Kidney Wilms Tumor, Rhabdoid Tumor of the Kidney, Stage II Kidney Wilms Tumor, Stage IV Kidney Wilms Tumor, Stage I Kidney Wilms Tumor.
What interventions are being tested in trial NCT00945009?
The interventions under investigation include: Radiation Therapy (RADIATION), Doxorubicin Hydrochloride (DRUG), Therapeutic Conventional Surgery (PROCEDURE), Dactinomycin (BIOLOGICAL), Vincristine Sulfate (DRUG).
Who is sponsoring clinical trial NCT00945009?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00945009 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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