Conditions

Endometrial Cancer Kidney Cancer Ovarian Cancer Pheochromocytoma Sarcoma

Keywords

adult angiosarcomaadult fibrosarcomaadult leiomyosarcomaadult liposarcomaadult neurofibrosarcomaadult synovial sarcomastage III adult soft tissue sarcomarecurrent adult soft tissue sarcomaadult alveolar soft-part sarcomaadult epithelioid sarcomaadult malignant fibrous histiocytomaadult malignant hemangiopericytomaadult malignant mesenchymomaadult rhabdomyosarcomalocalized benign pheochromocytomaregional pheochromocytomarecurrent pheochromocytomastage II uterine sarcomastage III uterine sarcomarecurrent uterine sarcomauterine carcinosarcomauterine leiomyosarcomaendometrial stromal sarcomaovarian sarcomaclear cell sarcoma of the kidneystage II adult soft tissue sarcoma

Interventions

filgrastimBiological

doxorubicin hydrochlorideDrug

ifosfamideDrug

Eligibility Criteria

Age16 Years - 69 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically proven soft tissue sarcoma that is amenable to definitive surgery no more than 8 weeks after biopsy or inadequate surgery * Eligible subtypes: * Alveolar soft part sarcoma * Angiosarcoma * Fibrosarcoma * Leiomyosarcoma * Malignant fibrous histiocytoma * Liposarcoma (round cell and pleomorphic) * Miscellaneous sarcoma (including pelvic mixed mesodermal tumors) * Malignant paraganglioma * Neurogenic sarcoma * Rhabdomyosarcoma * Synovial sarcoma * Unclassifiable sarcoma * Ineligible subtypes: * Chondrosarcoma * Dermatofibrosarcoma * Embryonal rhabdomyosarcoma * Ewing's sarcoma * Kaposi's sarcoma * Liposarcoma (myxoid and well differentiated) * Malignant mesothelioma * Neuroblastoma * Osteosarcoma * Confirmed high-grade tumor (i.e., Trojani Grade II or III) * No metastases on staging with chest x-ray and thoracic CT scan * No regional lymph node involvement * Locally recurrent disease allowed * Interval of 3 months or more between definitive surgery and recurrence PATIENT CHARACTERISTICS: Age: * 16 to 69 Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * WBC greater than 4,000/mm\^3 * Platelet count greater than 120,000/mm\^3 * No bleeding disorders Hepatic: * Bilirubin no greater than 1.25 times normal * No severe hepatic dysfunction Renal: * Creatinine less than 1.6 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No clear history of angina * No documented myocardial infarction * No existing cardiac failure Other: * No serious infection * No other malignancy except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior systemic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to affected area Surgery: * See Disease Characteristics

Sponsors & Collaborators

NCIC Clinical Trials Group
Research networkcollaborator
European Organisation for Research and Treatment of Cancer - EORTC
Research networklead

Study Sites (45)

Karl-Franzens-University Graz

Graz, A-8010, Austria

Institut Jules Bordet

Brussels, 1000, Belgium

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Related Publications (2)

Le Cesne A, Van Glabbeke M, Woll PJ, et al.: The end of adjuvant chemotherapy (adCT) era with doxorubicin-based regimen in resected high-grade soft tissue sarcoma (STS): pooled analysis of the two STBSG-EORTC phase III clinical trials. [Abstract] J Clin Oncol 26 (Suppl 15): A-10525, 2008.
BACKGROUND
Woll PJ, Reichardt P, Le Cesne A, Bonvalot S, Azzarelli A, Hoekstra HJ, Leahy M, Van Coevorden F, Verweij J, Hogendoorn PC, Ouali M, Marreaud S, Bramwell VH, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group and the NCIC Clinical Trials Group Sarcoma Disease Site Committee. Adjuvant chemotherapy with doxorubicin, ifosfamide, and lenograstim for resected soft-tissue sarcoma (EORTC 62931): a multicentre randomised controlled trial. Lancet Oncol. 2012 Oct;13(10):1045-54. doi: 10.1016/S1470-2045(12)70346-7. Epub 2012 Sep 4.
PMID: 22954508DERIVED

MeSH Terms

Conditions

Endometrial NeoplasmsKidney NeoplasmsOvarian NeoplasmsPheochromocytomaSarcomaHemangiosarcomaFibrosarcomaLeiomyosarcomaLiposarcomaNeurofibrosarcomaSarcoma, SynovialSarcoma, Alveolar Soft PartHistiocytoma, Malignant FibrousHemangiopericytoma, MalignantMalignant mesenchymal tumorRhabdomyosarcomaSarcoma, Endometrial Stromal

Study Officials

Penella J. Woll, MD, PhD
Cancer Research Centre at Weston Park Hospital
STUDY CHAIR
Vivien H.C. Bramwell, MB, BS, PhD, FRCP
Tom Baker Cancer Centre - Calgary
STUDY CHAIR

Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (45)

Related Publications (2)

MeSH Terms

Conditions

Study Officials

Study Design

Study Record Dates

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (45)

Related Publications (2)

MeSH Terms

Conditions

Study Officials

Study Design

Study Record Dates

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Source record

Locations