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NCT02567435 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma
A Phase 3 study of Rhabdomyosarcoma and Embryonal Rhabdomyosarcoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 325
- Enrollment target
- 20
- Study locations
NCT02567435: Active Phase 3 study of Rhabdomyosarcoma and Embryonal Rhabdomyosarcoma, sponsored by National Cancer Institute (NCI).
NCT02567435 is a Phase 3 study of Rhabdomyosarcoma and Embryonal Rhabdomyosarcoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 325 participants, above the 60-participant average among 35 other Rhabdomyosarcoma trials with a reported enrollment target (442% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02567435, a Phase 3 study of Rhabdomyosarcoma and Embryonal Rhabdomyosarcoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 325 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride or vinorelbine) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and has an intermediate chance of coming back after treatment (intermediate risk). Drugs used 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. Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether chemotherapy plus temsirolimus is more effective than chemotherapy alone in treating patients with intermediate-risk rhabdomyosarcoma.
Primary Outcome
The Kaplan-Meier method will used to estimate 3-year EFS between the randomized treatment groups (Regimen A (VAC/VI) vs. Regimen B (VAC/VI/Temsirolimus)) using the log-rank test. EFS event is defined as the time from study entry until first occurrence of progression, relapse, second malignancy, or death.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- DRUG Irinotecan Hydrochloride
- BIOLOGICAL Dactinomycin
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Arizona
- Kingman Regional Medical Center - Kingman
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
- Banner University Medical Center - Tucson - Tucson
California
- Kaiser Permanente-Anaheim - Anaheim
- PCR Oncology - Arroyo Grande
- Kaiser Permanente-Bellflower - Bellflower
Alabama
- Children's Hospital of Alabama - Birmingham
- USA Health Strada Patient Care Center - Mobile
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2016-06-01 |
| Est. Completion | 2026-10-27 |
| Phase | Phase 3 |
What the registry record for NCT02567435 still lists
NCT02567435 is an interventional study that assigns participants to a tested intervention. The registered 325 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 35 other Rhabdomyosarcoma trials with a reported enrollment target (442% higher).
The record links to 6 conditions, with Rhabdomyosarcoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02567435 names 20 study sites across 5 states, led by Alaska, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT02567435 about?
NCT02567435 is a clinical study titled "Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma". This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride or vinorelbine) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabd...
What is the current status of trial NCT02567435?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 325 participants. The study started on 2016-06-01. Estimated completion is 2026-10-27.
What conditions does trial NCT02567435 study?
This clinical trial studies the following conditions: Rhabdomyosarcoma, Embryonal Rhabdomyosarcoma, Alveolar Rhabdomyosarcoma, Botryoid-Type Embryonal Rhabdomyosarcoma, Spindle Cell Rhabdomyosarcoma.
What interventions are being tested in trial NCT02567435?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Irinotecan Hydrochloride (DRUG), Dactinomycin (BIOLOGICAL).
Who is sponsoring clinical trial NCT02567435?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02567435 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02567435's enrollment target sits among peer trials
325 2nd of 35 the highest of 35 other Rhabdomyosarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rhabdomyosarcoma 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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