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| Tracking Information | |||||
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| First Received Date ICMJE | December 10, 1999 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | March 1998 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00004109 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma | ||||
| Official Title ICMJE | A Phase I Study of Preoperative Concurrent Chemoradiation for High-Risk Extremity and Trunk Soft Tissue Sarcomas | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of doxorubicin plus external-beam radiation therapy in treating patients who have soft tissue sarcoma. |
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| Detailed Description | OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of doxorubicin when combined with external beam radiotherapy in patients with high risk soft tissue sarcomas of the extremity or trunk. II. Assess the radiographic and pathologic response rates to this preoperative regimen in the subset of these patients with measurable disease. OUTLINE: This is a dose escalation study of doxorubicin. Patients receive doxorubicin IV bolus followed immediately by doxorubicin IV over 4 days every week for 5 weeks in the absence of unacceptable toxicity. Patients with measurable disease receive external beam radiotherapy 5 days a week for 5 weeks concurrently with doxorubicin treatment. Patients with measurable disease undergo surgical resection of the residual mass 4-7 weeks following completion of chemoradiation. Patients who have no measurable disease and have undergone prereferral excision undergo surgical resection of the prior surgical scar and tumor bed followed by external beam radiotherapy 5 days a week for 5 weeks. Cohorts of 3 patients receive escalating doses of doxorubicin until the maximum tolerated dose (MTD) is determined. Patients are followed every 3 months for 3 years, every 4 months for 2 years, and then annually for 5 years. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study at a rate of 5-6 patients per month. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Sarcoma | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Histologically or cytologically proven soft tissue sarcoma of the extremity or trunk Resectable grade 3, stage III with tumor greater than 5 cm Measurable disease OR nonmeasurable disease after prereferral excision PATIENT CHARACTERISTICS: Age: Over 16 Performance status: Karnofsky 70-100% Zubrod 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT or SGPT no greater than 3 times normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.8 mg/dL Cardiovascular: Ejection fraction greater than 50% for patients with prior cumulative doxorubicin dose of 450 mg/m2 Other: Prior malignancy allowed at the discretion of the protocol investigator No uncontrolled concurrent medical condition Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior doxorubicin based systemic chemotherapy allowed if prior total dose no greater than 450 mg/m2 Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy in the area of the primary tumor Anticipated radiotherapy field must not include perineum, scrotum, or vaginal introitus Surgery: See Disease Characteristics |
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00004109 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067332, MDA-ID-97335, NCI-G99-1598 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | December 2001 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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