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Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

Primary Purpose

Rhabdomyosarcoma, Malignant Soft Tissue

Status

Terminated

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Rhabdomyosarcoma

Eligibility Criteria

6 Months - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Institut Gustave Roussy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00162695

First Posted

September 9, 2005

Last Updated

September 9, 2005

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

1. Study Identification

Unique Protocol Identification Number

NCT00162695

Brief Title

Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Terminated

Study Start Date

July 1995 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhabdomyosarcoma, Malignant Soft Tissue

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Odile OBERLIN, Dr

Organizational Affiliation

Gustave Roussy, Cancer Campus, Grand Paris

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michael STEVENS, Dr

Organizational Affiliation

Hospital of Bristols, UK

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Gustave Roussy

City

Villejuif

ZIP/Postal Code

94800

Country

France

12. IPD Sharing Statement

Learn more about this trial

Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

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