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NCT01871766 · ClinicalTrials.gov registry record · Phase 2
Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy
A Phase 2 study of Rhabdomyosarcoma, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 115
- Enrollment target
- 4
- Study locations
NCT01871766: Active Phase 2 study of Rhabdomyosarcoma, sponsored by St. Jude Children's Research Hospital.
NCT01871766 is a Phase 2 study of Rhabdomyosarcoma that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 115 participants, above the 66-participant average among 35 other Rhabdomyosarcoma trials with a reported enrollment target (74% higher). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01871766, a Phase 2 study of Rhabdomyosarcoma, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 115 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study will treat participants with newly diagnosed, low, intermediate and high risk rhabdomyosarcoma (RMS) using multi-modality risk-adapted therapy with standard or intensified dose chemotherapy, radiation and surgical resection. Intermediate and high risk participants will receive an additional 12 weeks (4 cycles) of maintenance therapy with anti-angiogenic chemotherapy. PRIMARY OBJECTIVE: * Estimate event-free survival for intermediate risk participants treated with vincristine, dactinomycin and cyclophosphamide with the addition of maintenance anti-angiogenic therapy. SECONDARY OBJECTIVES: * Estimate the false negative rate and incidence of additional positive lymph nodes in participants undergoing sentinel lymph node biopsy followed by limited nodal dissection. * Maintain a high local control rate in participants treated with surgery and/or limited volume proton and photon radiation without dose escalation. * Define the incidence and type of failure in participants who receive risk-adapted local therapy relative to the primary tumor volume. * Establish the feasibility of delivering 4 cycles of maintenance anti-angiogenic chemotherapy in intermediate and high risk patients following standard chemotherapy. * Estimate the event free survival for high risk patients receiving interval dose compressed therapy and maintenance anti-angiogenic therapy. * Define the incidence of CTC grade 3 and higher toxicities (and specific grade 1-2 toxicities) related to proton beam therapy.
Primary Outcome
To estimate event-free survival for intermediate risk participants treated by vincristine-dactinomycin-cyclophosphamide (VAC) with the addition of maintenance anti-angiogenic therapy
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Surgical Resection
- DRUG Vincristine
- DRUG Dactinomycin
- PROCEDURE Radiation
Study Locations (4)
Florida
- University of Florida Proton Therapy Institute - Jacksonville
- Nemours Children's Clinic - Jacksonville
Tennessee
- St. Jude Children's Research Hospital - Memphis
Texas
- Cook Children's Medical Center - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2013-12-04 |
| Est. Completion | 2030-06 |
| Phase | Phase 2 |
What the registry record for NCT01871766 still lists
NCT01871766 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, above the 66-participant average among 35 other Rhabdomyosarcoma trials with a reported enrollment target (74% higher).
The record links to 1 condition, with Rhabdomyosarcoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01871766 reports a single indexed study location in Florida, Tennessee, Texas.
Frequently Asked Questions
What is clinical trial NCT01871766 about?
NCT01871766 is a clinical study titled "Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy". This study will treat participants with newly diagnosed, low, intermediate and high risk rhabdomyosarcoma (RMS) using multi-modality risk-adapted therapy with standard or intensified dose chemotherapy, radiation and surgical resection. Intermediate and high risk participants will receive an addition...
What is the current status of trial NCT01871766?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 115 participants. The study started on 2013-12-04. Estimated completion is 2030-06.
What conditions does trial NCT01871766 study?
This clinical trial studies the following conditions: Rhabdomyosarcoma.
What interventions are being tested in trial NCT01871766?
The interventions under investigation include: Cyclophosphamide (DRUG), Surgical Resection (PROCEDURE), Vincristine (DRUG), Dactinomycin (DRUG), Radiation (PROCEDURE).
Who is sponsoring clinical trial NCT01871766?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01871766 being conducted?
This trial has 4 study locations across Florida, Tennessee, Texas. 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 NCT01871766's enrollment target sits among peer trials
115 6th of 35 higher than 30 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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