Completed PHASE2 INTERVENTIONAL NCT00003955

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Metastatic Rhabdomyosarcoma or Sarcoma

A Phase II Up-Front Window Study of Irinotecan (CPT-11) Followed by Multimodal, Multiagent, Therapy for Selected Children and Adolescents With Newly Diagnosed Stage 4/Clinical Group IV Rhabdomyosarcoma: An IRS-V Study

Sponsor: Children's Oncology Group

Conditions Sarcoma

Interventions cyclophosphamide dactinomycin filgrastim irinotecan hydrochloride pegfilgrastim radiation therapy sargramostim vincristine sulfate

Updated 6 times since 2017 Last updated: Feb 12, 2014 Started: Sep 30, 1999 Primary completion: Jan 31, 2005 Completion: Oct 31, 2009

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

A PHASE2 clinical study on Sarcoma, this trial is completed. The trial is conducted by Children's Oncology Group and has accumulated 6 data snapshots since 1999. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

6 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Completed PHASE2

First recorded

Sep 1999

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 , Amarillo, United States , Ann Arbor, United States , Asheville, United States , Atlanta, United States , Auckland, New Zealand , Augusta, United States , Austin, United States and 167 more locations