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NCT00354835 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma
A Phase 3 study of Sarcoma and Rhabdomyosarcoma, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 481
- Enrollment target
- 20
- Study locations
NCT00354835: Completed Phase 3 study of Sarcoma and Rhabdomyosarcoma, sponsored by Children's Oncology Group.
NCT00354835 is a Phase 3 study of Sarcoma and Rhabdomyosarcoma that has completed, run by Children's Oncology Group. The registered enrollment target is 481 participants, below the 917-participant average among 122 other Sarcoma trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00354835, a Phase 3 study of Sarcoma and Rhabdomyosarcoma, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 481 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine sulfate, dactinomycin, cyclophosphamide, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with radiation therapy in treating patients with rhabdomyosarcoma.
Primary Outcome
Probability of no relapse, secondary malignancy, or death after 4 year in the study
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- DRUG Irinotecan Hydrochloride
- BIOLOGICAL Dactinomycin
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
- Mattel Children's Hospital UCLA - Los Angeles
- UCLA / Jonsson Comprehensive Cancer 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
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 481 participants |
| Start Date | 2006-12-26 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 3 |
What the finished NCT00354835 record still lists
NCT00354835 is an interventional study that assigns participants to a tested intervention. The registered 481 participants enrollment target is mid-sized for trials with a published cap, below the 917-participant average among 122 other Sarcoma trials with a reported enrollment target (48% lower).
The record links to 10 conditions, with Sarcoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00354835 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00354835 about?
NCT00354835 is a clinical study titled "Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma". This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine sulfate, dactinomycin, cycl...
What is the current status of trial NCT00354835?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 481 participants. The study started on 2006-12-26. Estimated completion is 2022-12-31.
What conditions does trial NCT00354835 study?
This clinical trial studies the following conditions: Sarcoma, Rhabdomyosarcoma, Adult Rhabdomyosarcoma, Childhood Alveolar Rhabdomyosarcoma, Childhood Embryonal Rhabdomyosarcoma.
What interventions are being tested in trial NCT00354835?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Irinotecan Hydrochloride (DRUG), Dactinomycin (BIOLOGICAL).
Who is sponsoring clinical trial NCT00354835?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00354835 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 Sarcoma
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 NCT00354835's enrollment target sits among peer trials
481 14th of 122 higher than 109 of 122 other Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sarcoma 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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