Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood
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|ClinicalTrials.gov Identifier: NCT00162695|
Recruitment Status : Terminated
First Posted : September 13, 2005
Last Update Posted : September 13, 2005
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 or disease||Intervention/treatment||Phase|
|Rhabdomyosarcoma Malignant Soft Tissue||Drug: Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||July 1995|
- To explore survival advantage for an intensified chemotherapy strategy in a randomised trial
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162695
|Institut Gustave Roussy|
|Villejuif, France, 94800|
|Principal Investigator:||Odile OBERLIN, Dr||Gustave Roussy, Cancer Campus, Grand Paris|
|Principal Investigator:||Michael STEVENS, Dr||Hospital of Bristols, UK|