Completed PHASE3 INTERVENTIONAL 2-arm NCT00075582

Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma

Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients With Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma

Sponsor: Children's Oncology Group

Conditions Adult Rhabdomyosarcoma Embryonal Childhood Rhabdomyosarcoma Embryonal-botryoid Childhood Rhabdomyosarcoma Previously Untreated Childhood Rhabdomyosarcoma

Interventions conventional surgery cyclophosphamide dactinomycin radiation therapy vincristine sulfate

Updated 11 times since 2017 Last updated: Nov 17, 2021 Started: Sep 4, 2004 Primary completion: Aug 13, 2012 Completion: Sep 30, 2021

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Adult Rhabdomyosarcoma and Embryonal Childhood Rhabdomyosarcoma and is currently completed. Children's Oncology Group leads this study, which shows 11 recorded versions since 2004 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

11 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Dec 2021 — Jul 2024 [monthly]

Completed PHASE3

Status: Active Not Recruiting → Completed
Jan 2021 — Dec 2021 [monthly]

Active Not Recruiting PHASE3

▶ Show 6 earlier versions

Dec 2020 — Jan 2021 [monthly]

Active Not Recruiting PHASE3
Jan 2020 — Dec 2020 [monthly]

Active Not Recruiting PHASE3

Status: Unknown Status → Active Not Recruiting
Nov 2018 — Jan 2020 [monthly]

Unknown Status PHASE3

Status: Active Not Recruiting → Unknown Status
Jun 2018 — Nov 2018 [monthly]

Active Not Recruiting PHASE3
Feb 2017 — Jun 2018 [monthly]

Active Not Recruiting PHASE3
Jan 2017 — Feb 2017 [monthly]

Active Not Recruiting PHASE3

First recorded

Sep 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Children's Oncology Group
National Cancer Institute (NCI)

Data source: Children's Oncology Group

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Akron, United States , Albany, United States , Albuquerque, United States , Ann Arbor, United States , Arcadia, United States , Asheville, United States , Atlanta, United States , Aurora, United States , Baltimore, United States , Bangor, United States and 127 more locations