Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma
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.
Drug: Doxorubicin Hydrochloride
Radiation: Radiation Therapy (RT)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Preoperative Concurrent Chemoradiation for High-Risk Extremity and Trunk Soft Tissue Sarcomas|
- Maximum Tolerated Dose (MTD) [ Time Frame: Continousouly during 5 weeks treatment ] [ Designated as safety issue: Yes ]MTD of doxorubicin intravenous (IV) based on presence of dose limiting toxicities. For dose-finding purposes, a dose-limiting toxicity (DLT) was defined as grade 3 or greater treatment-related cutaneous toxicity
|Study Start Date:||March 1998|
|Study Completion Date:||April 2011|
|Primary Completion Date:||September 2001 (Final data collection date for primary outcome measure)|
|Experimental: Doxorubicin + External-Beam RT||
Drug: Doxorubicin Hydrochloride
Doxorubicin dose will not exceed 20 mg/m2 per week IV over 4 days every week for 5 weeks
Other Name: doxorubicinRadiation: Radiation Therapy (RT)
External-beam radiotherapy at a dose of 50 Gy (2.0 x 25 fractions, weeks 1-5).
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 intravenous (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004109
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Peter W. Pisters, MD||M.D. Anderson Cancer Center|