Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood - Full Text View

Purpose

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.

Condition	Intervention	Phase
Rhabdomyosarcoma Malignant Soft Tissue	Drug: Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide	Phase III

MedlinePlus related topics:

Cancer Soft Tissue Sarcoma

ChemIDplus related topics:

Ifosfamide Etoposide Vincristine sulfate Vincristine Etoposide phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:

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

Estimated Enrollment:	400
Study Start Date:	July 1995

Eligibility

Ages Eligible for Study:	6 Months to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162695

Locations


France
	Institut Gustave Roussy
	Villejuif, France, 94800

Sponsors and Collaborators

Institut Gustave Roussy

Investigators


Principal Investigator:	Odile OBERLIN, Dr	Institut Gustave Roussy

Principal Investigator:	Michael STEVENS, Dr	Hospital of Bristols, UK

More Information

Study ID Numbers:	RMS95
First Received:	September 9, 2005
Last Updated:	September 9, 2005
ClinicalTrials.gov Identifier:	NCT00162695
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue

Ifosfamide

Soft Tissue Neoplasms

Malignant mesenchymal tumor

Sarcoma

Vincristine

Etoposide phosphate

Etoposide

Soft tissue sarcomas

Isophosphamide mustard

Rhabdomyosarcoma

Additional relevant MeSH terms:

Neoplasms, Muscle Tissue

Neoplasms

Neoplasms by Histologic Type

Myosarcoma

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	Institut Gustave Roussy
Information provided by:	Institut Gustave Roussy
ClinicalTrials.gov Identifier:	NCT00162695