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Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

NCT00162695 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2005-09-13

No results posted yet for this study

Summary

Objective of the study objectives was to explore survival advantage for an intensified chemotherapy strategy in a randomised trial.

IVA (ifosfamide, vincristine, actinomycin D) or a 6 drug combination (IVA + carboplatin, epirubicin, etoposide) both delivered over 27 weeks. Cumulative dose / m2 = ifosfamide 54g (both arms), epirubicin 450 mg, etoposide 1350 mg (6 drug). Delivery of radiotherapy was determined according to site and / or response to chemotherapy ± surgery.

The study was powered to detect 10% difference in 3 year OS.

Conditions

  • Rhabdomyosarcoma
  • Malignant Soft Tissue

Interventions

DRUG

Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • Odile OBERLIN, Dr · Gustave Roussy, Cancer Campus, Grand Paris

  • Michael STEVENS, Dr · Hospital of Bristols, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00162695 on ClinicalTrials.gov