CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 481 enrolled
Drug / intervention
Cyclophosphamide +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00354835
NCT00354835Phase 3Completed

Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine and Irinotecan (VI) for Patients With Intermediate-Risk Rhabdomyosarcoma (RMS)

Children's Oncology Group·interventional·Posted Jul 20, 2006·Updated Jan 31, 2023

In Brief

A Phase 3 clinical trial evaluating Cyclophosphamide, Dactinomycin, and 5 other interventions for Adult Rhabdomyosarcoma and 9 related conditions. Completed, enrolled 481 participants across 226 sites in 6 countries.

Detailed 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.

Study Details

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 20, 2006
Enrollment StartDec 26, 2006
Primary CompletionDec 31, 2014
Study CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 19.9 years ago

Interventions

Cyclophosphamidedrug

Given IV

Dactinomycinbiological

Given IV

Irinotecan Hydrochloridedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Questionnaire Administrationother

Ancillary studies

Radiation Therapyradiation

Undergo radiotherapy

Vincristine Sulfatedrug

Given IV