Surgery Followed by Chemotherapy in Treating Young Patients With Soft Tissue Sarcoma - Full Text View

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

Drug Information available for: Dactinomycin

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

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


Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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
Study First Received:	November 1, 1999
Last Updated:	December 3, 2013
Health Authority:	United States: Federal Government

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:


Histiocytoma Histiocytoma, Benign Fibrous Histiocytoma, Malignant Fibrous Neoplasms Neoplasms by Histologic Type	Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Sarcoma

ClinicalTrials.gov processed this record on March 03, 2015