Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Chi... | NCT00162695

Studies
Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood

NCT00162695

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Terminated

Last Update Posted

Sep 13, 2005Estimated

Enrollment

400

Phase

Phase 3

Conditions

Rhabdomyosarcoma
Malignant Soft Tissue

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1995

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2005

Last Update Posted Date

Sep 13, 2005Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400

Name	Type	Description	Arm Group Labels	Other Names
Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To explore survival advantage for an intensified chemotherapy strategy in a randomised trial

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Odile OBERLIN, Dr	Gustave Roussy, Cancer Campus, Grand Paris	Principal Investigator
Michael STEVENS, Dr	Hospital of Bristols, UK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Gustave Roussy		Villejuif		94800	France

Condition Browse Module

MeSH Terms

ID	Term
D012208	Rhabdomyosarcoma

Ancestor Terms

ID	Term
D009217	Myosarcoma
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007069	Ifosfamide
D014750	Vincristine
D015251	Epirubicin
D016190	Carboplatin
D005047	Etoposide

Ancestor Terms

ID	Term
D003520	Cyclophosphamide
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds

Browse Leaves

Not provided

Browse Branches

Not provided