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Surgery Followed by Chemotherapy in Treating Young Patients With Soft Tissue Sarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002898
First Posted: January 27, 2003
Last Update Posted: December 4, 2013
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.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: MMT 95 Study For Rhabdomyosarcoma and Other Malignant Soft Tissue Tumors of Childhood

Resource links provided by NLM:

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

Further study details as provided by National Cancer Institute (NCI):
Estimated Enrollment: 400
Study Start Date: January 1995
Study Completion Date: December 2009
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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:
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.
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 Submitted: November 1, 1999
First Posted: January 27, 2003
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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