Surgery Followed by Chemotherapy in Treating Young Patients With Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT00002898|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 4, 2013
|First Submitted Date ICMJE||November 1, 1999|
|First Posted Date ICMJE||January 27, 2003|
|Last Update Posted Date||December 4, 2013|
|Study Start Date ICMJE||January 1995|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00002898 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Surgery Followed by Chemotherapy in Treating Young Patients With Soft Tissue Sarcoma|
|Official Title ICMJE||MMT 95 Study For Rhabdomyosarcoma and Other Malignant Soft Tissue Tumors of Childhood|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with surgery and/or radiation therapy may kill more tumor cells.
PURPOSE: This randomized phase III trial is studying surgery followed by different regimens of combination chemotherapy given together with radiation therapy and/or additional surgery to compare how well they work in treating patients with soft tissue sarcoma.
OUTLINE: This is a randomized study for patients with high-risk, nonmetastatic sarcoma, except those with the following characteristics: age less than 6 months, stage I/II non-alveolar orbital tumor, stage III disease, or age less than 3 years with parameningeal disease. Patients are stratified according to disease type (rhabdomyosarcoma (RMS) vs non-RMS disease), parameningeal site of disease, and participating center. Patients with RMS are further randomized by alveolar histology. Randomization occurs after the first course of chemotherapy.
All patients, regardless of disease stage, are registered to this study and outcome is followed, although patients with metastatic RMS or non-RMS malignant mesenchymal tumors are referred for treatment on the SIOP-MMT-98 study. Patients diagnosed more than 8 weeks prior to entry or who are unavailable for follow-up are not treated on study. Doses are modified for patients under 1 year of age or under 10 kg of body weight. All other patients are assigned therapy based on risk group.
After surgery, patients with complete resection and with proven or possible chemosensitive histologies proceed to chemotherapy on the low-risk regimen. Patients with questionable completeness of resection proceed to chemotherapy for standard-risk or high-risk tumors, as appropriate. Regardless of resection results, patients who underwent scrotal surgery for paratesticular tumors proceed to chemotherapy for standard-risk tumors. Alveolar RMS is considered high risk.
LOW-RISK TUMORS (T1 N0 M0): Strategy 951
STANDARD-RISK TUMORS (T1-2 N0 M0): Strategy 952
HIGH-RISK TUMORS: Strategy 953
TREATMENT FOR RELAPSE
Patients are followed every 2 months until 2 years after diagnosis, every 3 months for 1 year, every 6 months for 2 years, and then annually until 10 years after diagnosis.
PROJECTED ACCRUAL: A total of 400 patients with high-risk nonmetastatic disease will be accrued for this study within approximately 4 years.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Treatment
|Study Arms ICMJE||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE
|Original Enrollment ICMJE||Not Provided|
|Actual Study Completion Date ICMJE||December 2009|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages ICMJE||up to 17 Years (Child)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United Kingdom|
|Removed Location Countries|
|NCT Number ICMJE||NCT00002898|
|Other Study ID Numbers ICMJE||CDR0000065228
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Societe Internationale d'Oncologie Pediatrique|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||May 1999|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP