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Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma Clinical research trials and Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma medical trials take place in many of places 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 usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma. Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma clinical trial. Test subjects typically obtain the finest healthcare available for their Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma  Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma
Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma
For Condition: stage 3 adult soft tissue sarcoma,recurrent adult soft tissue sarcoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , M.D. Anderson Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterT. Pisters, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000067332; MDA-ID-97335,NCI-G99-1598
Study Start Date: March 1998
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004109
Other Stage 3 Adult Soft Tissue Sarcoma Studies:
1. Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Primary or Recurrent Sarcoma
2. Whole-Body Hyperthermia Plus Chemotherapy in Treating Patients With Advanced Sarcoma
3. Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma
4. Radiation Therapy Plus Doxorubicin in Treating Patients With Resectable Primary or Recurrent Retroperitoneal Soft Tissue Sarcoma
5. Chemotherapy, SU5416, Radiation Therapy, and Surgery in Treating Patients With Soft Tissue Sarcoma
Related Studies:
Other stage 3 adult soft tissue sarcoma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma
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