EpSSG (European Soft Tissue Sarcoma Study Group) Protocol for Non-Metastatic Rhabdomyosarcoma in Children
Overview[ - collapse ][ - ]
| Purpose | The purpose of the study is achieve standardization treatment of low and intermediate risk rhabdomyosarcoma patients, with an attempt to improve treatment results in high and very high risk patients by the addition of doxorubicin as induction treatment and at the maintenance phase. |
|---|---|
| Condition | Rhabdomyosarcoma |
| Intervention | Drug: doxorubicin, cytoxan |
| Phase | Phase 4 |
| Sponsor | Sheba Medical Center |
| Responsible Party | Sheba Medical Center |
| ClinicalTrials.gov Identifier | NCT00339118 |
| First Received | June 19, 2006 |
| Last Updated | June 19, 2006 |
| Last verified | June 2006 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 19, 2006 |
|---|---|
| Last Updated Date | June 19, 2006 |
| Start Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | EpSSG (European Soft Tissue Sarcoma Study Group) Protocol for Non-Metastatic Rhabdomyosarcoma in Children |
|---|---|
| Official Title | Not Provided |
| Brief Summary | The purpose of the study is achieve standardization treatment of low and intermediate risk rhabdomyosarcoma patients, with an attempt to improve treatment results in high and very high risk patients by the addition of doxorubicin as induction treatment and at the maintenance phase. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label |
| Condition | Rhabdomyosarcoma |
| Intervention | Drug: doxorubicin, cytoxan |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
|---|---|
| Estimated Enrollment | Not Provided |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - child - non metastatic rhabdomyosarcoma - adequate heart, kidney, liver function Exclusion Criteria: - age over 21 years, under 6 months - metastatic disease - heart, kidney, liver disease |
| Gender | Both |
| Ages | 6 Months |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Iris Kventsel, MD 97235303037 iris.kventsel@sheba.health.gov.il |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00339118 |
|---|---|
| Other Study ID Numbers | SHEBA-06-4013-IK-CTIL |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Sheba Medical Center |
| Study Sponsor | Sheba Medical Center |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Iris Kventsel, MD Sheba Medical Center |
| Verification Date | June 2006 |