Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rhabdomyosarcoma Malignant Soft Tissue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Odile OBERLIN, Dr

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Michael STEVENS, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospital of Bristols, UK

Locations

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Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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RMS95

Identifier Type: -

Identifier Source: org_study_id