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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004109 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: doxorubicin hydrochloride Radiation: radiation therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study of Preoperative Concurrent Chemoradiation for High-Risk Extremity and Trunk Soft Tissue Sarcomas |
| Study Start Date: | March 1998 |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Peter W.T. Pisters, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000067332, MDA-ID-97335, NCI-G99-1598 |
| Study First Received: | December 10, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004109 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III adult soft tissue sarcoma recurrent adult soft tissue sarcoma |
|
Neoplasms, Connective and Soft Tissue Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses |
Sarcoma Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin |