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

Sponsor:

Information provided by:

National Cancer Institute (NCI)

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Childhood Malignant Fibrous Histiocytoma of Bone Sarcoma	Biological: dactinomycin Drug: carboplatin Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: brachytherapy Radiation: radiation therapy	Phase 3

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Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	400 participants
Allocation:	Randomized
Primary Purpose:	Treatment
Official Title:	MMT 95 Study For Rhabdomyosarcoma and Other Malignant Soft Tissue Tumors of Childhood
Study Start Date :	January 1995
Actual Study Completion Date :	December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Soft Tissue Sarcoma

Genetic and Rare Diseases Information Center resources: Neuroepithelioma Soft Tissue Sarcoma Ewing Sarcoma Ewing's Family of Tumors Leiomyosarcoma Liposarcoma Synovial Sarcoma Malignant Peripheral Nerve Sheath Tumor Neurofibrosarcoma Undifferentiated Pleomorphic Sarcoma Desmoplastic Small Round Cell Tumor Fibrosarcoma Alveolar Soft Part Sarcoma Epithelioid Sarcoma Hemangiopericytoma Malignant Mesenchymoma

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	up to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary soft tissue sarcoma:
- Rhabdomyosarcoma
- Non-rhabdomyosarcoma
- Soft tissue primitive neuroectodermal tumor (PNET)
- Extraosseous Ewing's sarcoma

PATIENT CHARACTERISTICS:

Age:

Under 18

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

PRIOR CONCURRENT THERAPY:

Biologic:

Not specified

Chemotherapy:

Not specified

Endocrine:

Not specified

Radiotherapy:

Not specified

Surgery:

Prior primary surgery allowed

Other:

No other prior therapy

Contacts and Locations

Information from the National Library of Medicine

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): NCT00002898

Locations


United Kingdom
Institute of Child Health
Bristol, England, United Kingdom, BS2 8AE

Sponsors and Collaborators

Societe Internationale d'Oncologie Pediatrique

Investigators


Study Chair:	M. C. G. Stevens, MD	Institute of Child Health at University of Bristol

More Information

Publications of Results:

Oberlin O, Rey A, Sanchez de Toledo J, Martelli H, Jenney ME, Scopinaro M, Bergeron C, Merks JH, Bouvet N, Ellershaw C, Kelsey A, Spooner D, Stevens MC. Randomized comparison of intensified six-drug versus standard three-drug chemotherapy for high-risk nonmetastatic rhabdomyosarcoma and other chemotherapy-sensitive childhood soft tissue sarcomas: long-term results from the International Society of Pediatric Oncology MMT95 study. J Clin Oncol. 2012 Jul 10;30(20):2457-65. doi: 10.1200/JCO.2011.40.3287. Epub 2012 Jun 4.

Other Publications:

Chisholm JC, Marandet J, Rey A, Scopinaro M, de Toledo JS, Merks JH, O'Meara A, Stevens MC, Oberlin O. Prognostic factors after relapse in nonmetastatic rhabdomyosarcoma: a nomogram to better define patients who can be salvaged with further therapy. J Clin Oncol. 2011 Apr 1;29(10):1319-25. doi: 10.1200/JCO.2010.32.1984. Epub 2011 Feb 28.

Orbach D, Mc Dowell H, Rey A, Bouvet N, Kelsey A, Stevens MC. Sparing strategy does not compromise prognosis in pediatric localized synovial sarcoma: experience of the International Society of Pediatric Oncology, Malignant Mesenchymal Tumors (SIOP-MMT) Working Group. Pediatr Blood Cancer. 2011 Dec 15;57(7):1130-6. doi: 10.1002/pbc.23138. Epub 2011 Apr 14.

Defachelles AS, Rey A, Oberlin O, Spooner D, Stevens MC. Treatment of nonmetastatic cranial parameningeal rhabdomyosarcoma in children younger than 3 years old: results from international society of pediatric oncology studies MMT 89 and 95. J Clin Oncol. 2009 Mar 10;27(8):1310-5. doi: 10.1200/JCO.2008.19.5701. Epub 2009 Feb 9.


ClinicalTrials.gov Identifier:	NCT00002898 History of Changes
Other Study ID Numbers:	CDR0000065228 SIOP-MMT-95 EU-96035
First Posted:	January 27, 2003 Key Record Dates
Last Update Posted:	December 4, 2013
Last Verified:	May 1999

Keywords provided by National Cancer Institute (NCI):


embryonal childhood rhabdomyosarcoma alveolar childhood rhabdomyosarcoma pleomorphic childhood rhabdomyosarcoma mixed childhood rhabdomyosarcoma embryonal-botryoid childhood rhabdomyosarcoma nonmetastatic childhood soft tissue sarcoma childhood fibrosarcoma childhood synovial sarcoma childhood malignant hemangiopericytoma childhood liposarcoma	childhood alveolar soft-part sarcoma childhood leiomyosarcoma childhood neurofibrosarcoma childhood angiosarcoma childhood epithelioid sarcoma childhood malignant fibrous histiocytoma of bone childhood malignant mesenchymoma previously untreated childhood rhabdomyosarcoma childhood desmoplastic small round cell tumor localized Ewing sarcoma/peripheral primitive neuroectodermal tumor

Additional relevant MeSH terms:


Sarcoma Rhabdomyosarcoma Histiocytoma Histiocytoma, Benign Fibrous Histiocytoma, Malignant Fibrous Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Myosarcoma Neoplasms, Muscle Tissue Neoplasms, Fibrous Tissue Neoplasms, Connective Tissue Cyclophosphamide Ifosfamide Carboplatin	Etoposide Vincristine Epirubicin Dactinomycin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors

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