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

NCT00002898 | Completed Phase 3

• 3 other identifiers: CDR0000065228SIOP-MMT-95EU-96035
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Malignant Fibrous Histiocytoma of Bone; Sarcoma

Keywords

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

Interventions

dactinomycin BIOLOGICAL

carboplatin DRUG

cyclophosphamide DRUG

epirubicin hydrochloride DRUG

etoposide DRUG

ifosfamide DRUG

vincristine sulfate DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

brachytherapy RADIATION

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Societe Internationale d'Oncologie Pediatrique: lead

Study Sites (1)

Institute of Child Health

Bristol, England, BS2 8AE, United Kingdom

Location

Related Publications (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.

  PMID: 21357778 BACKGROUND

• 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.

  PMID: 21495161 BACKGROUND

• 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.

  PMID: 19204197 BACKGROUND

• 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.

  PMID: 22665534 RESULT

MeSH Terms

Conditions

Sarcoma; Fibrosarcoma; Hemangiopericytoma, Malignant; Liposarcoma; Hemangiosarcoma; Malignant mesenchymal tumor; Desmoplastic Small Round Cell Tumor; Neuroectodermal Tumors, Primitive, Peripheral

Interventions

Dactinomycin; Carboplatin; Cyclophosphamide; Epirubicin; Etoposide; Ifosfamide; Vincristine; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Brachytherapy; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Adipose Tissue; Neoplasms, Vascular Tissue; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Coordination Complexes; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Oxazines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Indolizidines; Indolizines; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• M. C. G. Stevens, MD

  Institute of Child Health at University of Bristol

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: January 1, 1995
• Study Completion: December 1, 2009
• Last Updated: December 4, 2013

Record last verified: 1999-05

Locations

GB (1)