Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00162695

Enrollment

400

Registered

2005-09-13

Start date

1995-07-31

Completion date

Unknown

Last updated

2005-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Soft Tissue, Rhabdomyosarcoma

Brief 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.

Interventions

DRUGIfosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 21 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To explore survival advantage for an intensified chemotherapy strategy in a randomised trial	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026