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Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma Clinical research trials and Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma. Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma clinical trial. Human subjects often receive the most effective healthcare possible for their Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma  Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma
Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma
For Condition: adult soft tissue sarcoma,clear cell sarcoma of the kidney,ovarian sarcoma,Pheochromocytoma,uterine sarcoma
Status: No longer recruiting
Sponsor(s): EORTC Soft Tissue and Bone Sarcoma Cooperative Group , National Cancer Institute of Canada
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether giving chemotherapy after surgery is more effective than surgery alone in treating soft tissue sarcoma. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients who have soft tissue sarcoma.
Details: OBJECTIVES: - Compare the local disease control, overall survival, and relapse-free survival in patients with high-grade soft tissue sarcoma treated with adjuvant high-dose doxorubicin and ifosfamide plus filgrastim (G-CSF) vs no adjuvant chemotherapy and G-CSF after definitive surgery. - Compare the toxicity and morbidity of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, site of primary tumor (extremity vs trunk, including shoulder, pelvic girdle, head, or neck vs central, including intrathoracic, visceral, uterine, or retroperitoneal), size of primary tumor (less than 5 cm vs 5 cm or greater in largest diameter), postoperative radiotherapy (yes vs no), and isolated limb perfusion therapy (yes vs no). Some patients undergo isolated limb perfusion therapy with cytotoxics and/or cytokines. No more than 8 weeks after biopsy or inadequate surgery, patients undergo definitive surgery. Patients with complete resection undergo radiotherapy assessment and then randomization. Patients with incomplete or marginal resection (except for central lesions) undergo re-excision and, in the absence of macroscopic disease, assessment for postoperative radiotherapy followed by randomization. - Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive no adjuvant chemotherapy or filgrastim (G-CSF). Beginning within 6 weeks after surgery, eligible patients undergo radiotherapy as outlined below. - Arm II: Beginning within 4 weeks after surgery, patients receive high-dose doxorubicin IV over 20 minutes followed by ifosfamide IV over 24 hours and G-CSF subcutaneously daily beginning 24 hours after completion of ifosfamide infusion and continuing for 10 days. Treatment continues every 3 weeks for 5 courses. Beginning within 6 weeks after completion of chemotherapy, eligible patients undergo radiotherapy as outlined below. - Radiotherapy: Patients with incomplete or marginal resection undergo radiotherapy 5 days a week for 6-6.6 weeks. Patients with complete microscopic resection undergo radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 1 week. Patients are followed every 2 months for 1 year, every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 3.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/69 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PenellaWoll, , Weston Park Hospital
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Middlesex Hospital- Meyerstein Institute
London, England, WIT 3AA
United Kingdom
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Centre Hospitalier Universitaire Vaudois
Lausanne, , CH-1011
Switzerland
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Institut Gustave Roussy
Villejuif, , F-94805
France
Hospital de la Santa Cruz I Sant Pau
Barcelona, , 08025
Spain
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan), , 20133
Italy
Karl-Franzens-University Graz
Graz, , A-8010
Austria
Daniel Den Hoed Cancer Center at Erasmus University Medical Center
Rotterdam, , 3075 EA
Netherlands
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Canada
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
United Kingdom
Kantonsspital - St. Gallen
St. Gallen, , CH-9007
Switzerland
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
Canada
Inselspital, Bern
BERN, , CH-3010
Switzerland
Eberhard Karls Universitaet
Tuebingen, , D-72076
Germany
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Universitaets-Krankenhaus Eppendorf
Hamburg, , D-20246
Germany
Antoni van Leeuwenhoek Hospital
Amsterdam, , 1066 CX
Netherlands
Weston Park Hospital
Sheffield, England, S1O 2SJ
United Kingdom
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
McGill University
Montreal, Quebec, H2W 1S6
Canada
Hopital Universitaire Erasme
Brussels, , 1070
Belgium
Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa
Lisbon, , 1099-023 Codex
Portugal
Aarhus Kommunehospital
Aarhus, , DK-8000
Denmark
Academisch Ziekenhuis Groningen
Groningen, , 9713 EZ
Netherlands
Robert Roessle Klinik
Berlin, , D-13122
Germany
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
United Kingdom
Royal Marsden NHS Trust - London
London, England, SW3 6JJ
United Kingdom
St. James's Hospital
Leeds, England, LS9 7TF
United Kingdom
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Rigshospitalet
Copenhagen, , 2100
Denmark
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
United Kingdom
Cliniques Universitaires Saint-Luc
Brussels, , 1200
Belgium
Centre Leon Berard
Lyon, , 69373
France
Institut Jules Bordet
Brussels, , 1000
Belgium
CHU de la Timone
Marseille, , 13385
France
Klinikum Grosshadern
Munich, , D-81377
Germany
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5
Canada
National Cancer Institute - Bratislava
Bratislava, , 833 10
Slovakia
Universitaetsklinikum Essen
ESSEN, , D-45122
Germany
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Canada
Additional Information:
Study ID Numbers: CDR0000064132; EORTC-62931,CAN-NCIC-SR3
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002641
Other Clear Cell Sarcoma Of The Kidney Studies:
1. Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma
2. Combination Chemotherapy Alone or With Radiation Therapy in Treating Children With Kidney Cancer
3. Chemotherapy Followed by Surgery and Radiation Therapy With or Without Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Wilms' Tumor or Clear Cell Sarcoma of the Kidney
4. Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors
Related Studies:
Other clear cell sarcoma of the kidney Clinical Trials
Other England Clinical Trials
Other Leeds Clinical Trials
Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma
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