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Doxorubicin With or Without Ifosfamide in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Doxorubicin With or Without Ifosfamide in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Doxorubicin With or Without Ifosfamide in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma Clinical research trials and Doxorubicin With or Without Ifosfamide in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma healthcare trials happen in hundreds of localities throughout 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Doxorubicin With or Without Ifosfamide in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma. Doxorubicin With or Without Ifosfamide in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Doxorubicin With or Without Ifosfamide in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma clinical trial. Subjects frequently obtain the most expert healthcare possible for their Doxorubicin With or Without Ifosfamide in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Doxorubicin With or Without Ifosfamide in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma  Doxorubicin With or Without Ifosfamide in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Doxorubicin With or Without Ifosfamide in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
For Condition: adult soft tissue sarcoma
Status: Recruiting
Sponsor(s): EORTC Soft Tissue and Bone Sarcoma Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether doxorubicin is more effective with or without ifosfamide in treating soft tissue sarcoma. PURPOSE: Randomizedphase III trial to compare the effectiveness of doxorubicin with or without ifosfamide in treating patients who have locally advanced or metastatic soft tissue sarcoma.
Details: OBJECTIVES: - Compare the progression-free and overall survival of patients with locally advanced or metastatic soft tissue sarcoma treated with doxorubicin with vs without ifosfamide as first-line therapy. - Compare the response in patients treated with these regimens. - Compare the treatment-related mortality of patients treated with these regimens. - Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to WHO performance status (0 vs 1), age group (less than 50 years of age vs 50 years of age and over), presence of liver metastases (yes vs no), histological grade (2 vs 3), and participating center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive doxorubicin IV on day 1. - Arm II: Patients receive doxorubicin IV on days 1-3 and ifosfamide IV over 4 hours on days 1-4. In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter. PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed soft tissue sarcoma - Locally advanced unresectable* OR metastatic disease - High-grade (grade 2-3) disease according to the FNLCC grading system NOTE: *Disease that could prove resectable (including pulmonary metastasectomy) after a response to chemotherapy is allowed - The following tumor types are eligible: - Malignant fibrous histiocytoma - Myxoid and round cell liposarcoma, pleomorphic liposarcoma, or dedifferentiated liposarcoma - Pleomorphic rhabdomyosarcoma - Synovial sarcoma - Myxofibrosarcoma, intermediate and high-grade - Fibrosarcoma - Leiomyosarcoma - Angiosarcoma - Malignant peripheral nerve sheath tumor - Epithelioid sarcoma - The following tumor types are not eligible: - Gastrointestinal stromal tumor - Uterine leiomyosarcoma - Mixed mesodermal tumor - Chondrosarcoma - Malignant mesothelioma - Neuroblastoma - Osteosarcoma - Ewing's sarcoma/primitive neuroectodermal tumor - Desmoplastic small round cell tumor - Embryonal rhabdomyosarcoma - Alveolar soft part sarcoma - Must have a measurable lesion with clinical evidence of progression within the past 6 weeks - Osseous lesions and pleural effusions are not considered measurable - No known or symptomatic CNS metastases PATIENT CHARACTERISTICS: Age - 18 to 60 Performance status - WHO 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.8 mg/dL - Albumin at least 2.5 g/dL Renal - Creatinine no greater than 1.4 mg/dL OR - Creatinine clearance greater than 65 mL/min Cardiovascular - LVEF normal by echocardiography or MUGA - No history of cardiovascular disease Other - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - No other severe medical illness - No psychosis - No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or basal cell skin cancer - No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up schedule PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for advanced or metastatic disease - Prior adjuvant chemotherapy allowed provided there was no disease progression within 6 months after completion of treatment Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to the sole index lesion Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
IanJudson, , National Cancer Research Institute (NCRI)
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-16-332-211
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Contact Person 32-3-821-3000
National Cancer Institute - Bratislava *Recruiting*
Bratislava, , 833 10
Slovakia
Recruiting Contact Person 421-7-5937-8111
Additional Information:
Study ID Numbers: CDR0000302584; EORTC-62012
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061984
Other Adult Soft Tissue Sarcoma Studies:
1. Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma
2. Vincristine, Dactinomycin, Cyclophosphamide, and Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
3. Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
4. Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors
5. Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma
Related Studies:
Other adult soft tissue sarcoma Clinical Trials
Other Clinical Trials
Other Bratislava Clinical Trials
Doxorubicin With or Without Ifosfamide in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
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