|
Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma Clinical research trials and Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma. Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma clinical trial. Participants oftentimes recieve the most expert healthcare available for their Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "I" Clinical Trials Conditions > Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma  Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
For Condition: Soft Tissue Sarcoma,Uterine Cancer
Status: No longer recruiting
Sponsor(s): EORTC Soft Tissue and Bone Sarcoma Cooperative Group ,
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 ifosfamide or doxorubicin is more effective for advanced or metastatic soft tissue sarcoma. PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with that of doxorubicin in treating patients who have advanced or metastatic soft tissue sarcoma.
Details: OBJECTIVES: I. Determine the progression free survival rate in patients with advanced or metastatic soft tissue sarcoma treated with either of two different regimens of ifosfamide or doxorubicin. II. Assess the toxic effects of these therapies and response rate in these patients. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized into one of 3 arms (continuous ifosfamide, ifosfamide daily for 3 days, or doxorubicin). Patients are stratified by performance status (0 vs 1), liver involvement (no vs yes), histological type (leiomyosarcoma vs synovial sarcoma vs other), and histological grade (1 vs 2 vs 3). Arm I: Patients receive doxorubicin by bolus infusion for 5-20 minutes once every 3 weeks. Arm II: Patients receive ifosfamide by intravenous infusion for 4 hours on days 1, 2, and 3 every three weeks. Arm III: Patients receive ifosfamide by intravenous infusion for 72 hours every 3 weeks. Patients are assessed after every 2 courses of therapy. Each course of therapy consists of 3 weeks of treatment. Patients may receive a maximum of 6 courses of therapy in the absence of toxicity and disease progression. Patients are followed every 12 weeks for survival. PROJECTED ACCRUAL: A total of 780 patients (260 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/65 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histolgically proven advanced or metastatic soft tissue sarcoma including the following: Malignant fibrous histiocytoma; Liposarcoma; Rhabdomyosarcoma; Synovial sarcoma; Malignant paraganglioma; Fibrosarcoma; Leiomyosarcoma; Angiosarcoma including haemangiopericytoma; Neurogenic sarcoma; Unclassified sarcoma; Mixed mesodermal tumor of the uterus - Measurable disease with evidence of progression in prior 6 weeks - No symptomatic or known CNS metastases --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No radiotherapy to the sole index lesion - Surgery: Not specified --Patient Characteristics-- - Age: 15 to 65 - Performance status: WHO 0-1 - Life expectancy: Not specified - Hematopoietic: WBC at least 3000/mm3; Neutrophil count greater than 2,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater 1.75 mg/dL; Albumin at least 25 g/L - Renal: Creatinine clearance greater than 70 mL/min - Cardiovascular: No history of uncontrolled cardiovascular disease - Other: Fertile women must use effective contraception; No other severe medical illness including psychosis; No prior primary malignant tumor except: Adequately treated carcinoma in situ of the cervix; Basal cell carcinoma
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulLorigan, Study Chair, EORTC Soft Tissue and Bone Sarcoma Cooperative Group
Institut Gustave Roussy
Villejuif, , F-94805
France
Hospital Insular de Gran Canaria
Las Palmas, , G.C.
Spain
Medizinische Hochschule Hannover
Hannover, , D-30625
Germany
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, , 02-781
Poland
Klinikum Grosshadern
Munich, , D-81377
Germany
National Cancer Institute - Bratislava
Bratislava, , 833 10
Slovakia
Royal Marsden NHS Trust
London, England, SW3 6JJ
United Kingdom
Antoni van Leeuwenhoekhuis
Amsterdam, , 1066 CX
Netherlands
National Institute of Oncology
Budapest, , 1125
Hungary
Centre Leon Berard
Lyon, , 69373
France
St. James's Hospital
Leeds, England, LS9 7TF
United Kingdom
Weston Park Hospital
Sheffield, England, S1O 2SJ
United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
United Kingdom
Rigshospitalet
Copenhagen, , 2100
Denmark
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
United Kingdom
Aarhus Kommunehospital
Aarhus, , DK-8000
Denmark
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
University Medical Center Nijmegen
Nijmegen, , NL-6252 HB
Netherlands
Middlesex Hospital- Meyerstein Institute
London, England, WIT 3AA
United Kingdom
Rotterdam Cancer Institute
Rotterdam, , 3075 EA
Netherlands
Leiden University Medical Center
Leiden, , 2300 CA
Netherlands
Additional Information:
Study ID Numbers: CDR0000066070; EORTC-62971
Study Start Date: January 1998
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003212
Other Soft Tissue Sarcoma Studies:
1. Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
2. Phase II Liposomal Vincristine for Pediatric and Adolescent Patients with Relapsed Malignancies
3. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma
4. Combination Chemotherapy Plus Amifostine in Treating Patients With Metastatic or Unresectable Cancer
Related Studies:
Other Soft Tissue Sarcoma Clinical Trials
Other Clinical Trials
Other Leuven Clinical Trials
Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
|
|
|
|
|
|
|
|
