Combination Chemotherapy in Treating Young Patients With Nonmetastatic Rhabdomyosarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00379457|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : September 21, 2006
Last Update Posted : August 12, 2013
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating rhabdomyosarcoma.
PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with nonmetastatic rhabdomyosarcoma.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Biological: dactinomycin Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: topotecan hydrochloride Drug: vincristine sulfate Drug: vinorelbine tartrate Procedure: conventional surgery Radiation: radiation therapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Official Title:||A Protocol For Nonmetastatic Rhabdomyosarcoma [RMS-2005]|
|Study Start Date :||June 2006|
|Estimated Primary Completion Date :||May 2011|
- Event-free survival
- Disease-free survival (in patients treated with maintenance chemotherapy)
- Overall survival
- Progression-free survival
- Response rate
- Toxicity as measured by NCI-CTC version 3
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): NCT00379457
|Study Chair:||Gianni Bisogno, MD||Azienda Ospedaliera di Padova|
|Study Chair:||Meriel Jenney, MD||Childrens Hospital for Wales|
|Study Chair:||Hans Merks, MD, PhD||Dutch Childhood Oncology Group|