Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

Phase 3TerminatedNCT00162695

Gustave Roussy, Cancer Campus, Grand Paris400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Rhabdomyosarcoma Malignant Soft Tissue

Interventions

Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposideDRUG

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age \> 6 months and \< 18 years * no distant metastases * diagnosis within previous 8 weeks without prior treatment except surgery * pathology available for central review * written consent according to institutional requirement Exclusion Criteria: * stage III (node positive) * stage I or II non alveolar orbital tumours * patients with parameningeal disease aged \< 3 years

Locations (1)

Institut Gustave Roussy

Villejuif, France

Outcomes

Primary Outcomes

To explore survival advantage for an intensified chemotherapy strategy in a randomised trial

Data from ClinicalTrials.gov

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