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Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma Clinical research trials and Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma. Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma clinical trial. Subjects typically recieve the finest healthcare available for their Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma  Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma
Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma
For Condition: localized osteosarcoma
Status: No longer recruiting
Sponsor(s): European Osteosarcoma Intergroup , Medical Research Council
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether chemotherapy and surgery plus G-CSF is more effective than chemotherapy and surgery alone in treating patients with osteosarcoma. PURPOSE: Randomized phase III trial to compare the effectiveness combination chemotherapy and surgery with or without G-CSF in treating patients who have newly diagnosed osteosarcoma.
Details: OBJECTIVES: I. Determine the overall and disease-free survival of patients with newly diagnosed osteosarcoma of the extremity treated with conventional vs intensive cisplatin and doxorubicin with or without filgrastim (G-CSF) before and after definitive surgery. II. Compare the toxicity of these regimens in these patients. III. Compare the response in patients treated with these regimens. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive conventional doxorubicin (DOX) IV over 4 hours on days 1-3 and cisplatin (CDDP) IV continuously on day 1. Treatment continues every 3 weeks for 2 courses. At week 6, patients undergo amputation or local resection based on pretherapy imaging and response to chemotherapy. Beginning 2 weeks after surgery, patients receive 4 additional courses of conventional chemotherapy. Arm II: Patients receive intensive DOX and CDDP as above on day 1 plus filgrastim (G-CSF) subcutaneously on days 4-13. Treatment continues every 2 weeks for 3 courses. At week 6, patients undergo definitive surgery as in arm I. Beginning 2 weeks after surgery, patients receive 3 additional courses of intensive DOX and CDDP with G-CSF. Patients who experience disease progression during preoperative chemotherapy undergo surgery earlier than scheduled and complete all scheduled chemotherapy (6 courses) after surgery, at the discretion of the surgeon and oncologist. Within 4 weeks after limb-sparing procedure, patients with inadequate margins undergo amputation, followed 2 weeks later by chemotherapy. Patients are followed monthly for 6 months, every 2 months for 6 months, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /40 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven resectable osteosarcoma of the long bone of an extremity - No parosteal (juxtacortical), periosteal, Pagetoid, or post-irradiation sarcoma - No distant metastases --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No other concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics - Surgery: See Disease Characteristics - Other: No prior therapy --Patient Characteristics-- - Age: 40 and under - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Neutrophil count at least 1,500/mm3 OR WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.2 mg/dL - Renal: Glomerular filtration rate at least 60 mL/min - Cardiovascular: No history of cardiac dysfunction - Other: No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarianneNooij, Study Chair, European Osteosarcoma Intergroup
Academisch Ziekenhuis Utrecht
Utrecht, , 3584 CX
Netherlands
Centre Eugene Marquis
Rennes, , 35064
France
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
Aarhus Kommunehospital
Aarhus, , DK-8000
Denmark
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Onze Lieve Vrouwe Gasthuis
Amsterdam, , 1091 HA
Netherlands
Cliniques Universitaires Saint-Luc
Brussels (Bruxelles), , 1200
Belgium
Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa
Lisbon, , 1099-023 Codex
Portugal
Institute of Oncology, Ljubljana
Ljubljana, , Sl-1000
Slovenia
Emma Kinderziekenhuis
Amsterdam, , NL-1100 DE
Netherlands
Institut Jules Bordet
Brussels (Bruxelles), , 1000
Belgium
Leiden University Medical Center
Leiden, , 2300 CA
Netherlands
King Faisal Specialist Hospital and Research Centre
Riyadh, , 11211
Saudi Arabia
Rigshospitalet
Copenhagen, , 2100
Denmark
St. James's Hospital
Leeds, England, LS9 7TF
United Kingdom
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Additional Information:
Study ID Numbers: CDR0000078531; EOI-80931,EORTC-80931,EU-93024
Study Start Date: August 1993
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002539
Other Localized Osteosarcoma Studies:
1. Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer
2. Interferon alfa and Thalidomide in Treating Patients With Soft Tissue Sarcoma or Bone Sarcoma
3. Neoadjuvant and Adjuvant Pamidronate With Induction and Maintenance Chemotherapy in Treating Patients With Osteosarcoma
4. Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma
5. Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma
Related Studies:
Other localized osteosarcoma Clinical Trials
Other Clinical Trials
Other Edegem Clinical Trials
Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma
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