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Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma
This study is ongoing, but not recruiting participants.
Study NCT00004109   Information provided by National Cancer Institute (NCI)
First Received: December 10, 1999   Last Updated: February 6, 2009   History of Changes

December 10, 1999
February 6, 2009
March 1998
 
 
 
Complete list of historical versions of study NCT00004109 on ClinicalTrials.gov Archive Site
 
 
 
Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma
A Phase I Study of Preoperative Concurrent Chemoradiation for High-Risk Extremity and Trunk Soft Tissue Sarcomas

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.

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.

Phase I
Interventional
Treatment
Sarcoma
  • Drug: doxorubicin hydrochloride
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004109
 
CDR0000067332, MDA-ID-97335, NCI-G99-1598
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Peter W.T. Pisters, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP