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NCT00352534 · ClinicalTrials.gov registry record · Phase 3
Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor
A Phase 3 study of Stage III Kidney Wilms Tumor and Stage II Kidney Wilms Tumor, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 3
- Development phase
- 808
- Enrollment target
- 20
- Study locations
NCT00352534: Active Phase 3 study of Stage III Kidney Wilms Tumor and Stage II Kidney Wilms Tumor, sponsored by Children's Oncology Group.
NCT00352534 is a Phase 3 study of Stage III Kidney Wilms Tumor and Stage II Kidney Wilms Tumor that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 808 participants, above the 300-participant average among 3 other Stage III Kidney Wilms Tumor trials with a reported enrollment target (169% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00352534, a Phase 3 study of Stage III Kidney Wilms Tumor and Stage II Kidney Wilms Tumor, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 808 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor. Drugs used in chemotherapy, such as vincristine, dactinomycin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors.Giving these treatments after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.
Primary Outcome
Probability of no relapse, secondary malignancy, or death after 4 year in the study.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Chest Radiography
- BIOLOGICAL Dactinomycin
- RADIATION 3-Dimensional Conformal Radiation Therapy
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- 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
- Cedars Sinai Medical Center - 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
- Sutter Medical Center Sacramento - Sacramento
- University of California Davis Comprehensive Cancer Center - Sacramento
Alabama
- Children's Hospital of Alabama - Birmingham
- University of Alabama at Birmingham Cancer Center - Birmingham
- USA Health Strada Patient Care Center - Mobile
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 808 participants |
| Start Date | 2006-11-06 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 3 |
What the registry record for NCT00352534 still lists
NCT00352534 is an interventional study that assigns participants to a tested intervention. The registered 808 participants enrollment target is mid-sized for trials with a published cap, above the 300-participant average among 3 other Stage III Kidney Wilms Tumor trials with a reported enrollment target (169% higher).
The record links to 3 conditions, with Stage III Kidney Wilms Tumor appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT00352534 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00352534 about?
NCT00352534 is a clinical study titled "Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor". This phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor. Drugs used in chemotherapy, such as vi...
What is the current status of trial NCT00352534?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 808 participants. The study started on 2006-11-06. Estimated completion is 2026-03-31.
What conditions does trial NCT00352534 study?
This clinical trial studies the following conditions: Stage III Kidney Wilms Tumor, Stage II Kidney Wilms Tumor, Stage I Kidney Wilms Tumor.
What interventions are being tested in trial NCT00352534?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Chest Radiography (PROCEDURE), Dactinomycin (BIOLOGICAL), 3-Dimensional Conformal Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT00352534?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00352534 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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