Combination Chemotherapy in Treating Patients With Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT00002492|
Recruitment Status : Completed
First Posted : April 22, 2004
Last Update Posted : December 15, 2016
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining cisplatin and doxorubicin in treating patients who have soft tissue sarcoma.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: cisplatin Drug: doxorubicin hydrochloride Drug: isolated limb perfusion Procedure: conventional surgery Radiation: brachytherapy Radiation: radiation therapy||Phase 2|
OBJECTIVES: I. Determine the response in patients with resectable soft tissue sarcoma of the extremity treated with neoadjuvant intra-arterial cisplatin and IV doxorubicin followed by limb-sparing procedure or amputation, adjuvant IV cisplatin and IV doxorubicin, and radiotherapy. II. Determine the chemotherapeutic response in tumor specimens of patients treated with this regimen.
OUTLINE: Neoadjuvant chemotherapy: Patients undergo arterial cannulation followed by cisplatin intra-arterially over 4 hours on day 1 and doxorubicin IV (beginning 15 minutes after completion of cisplatin infusion) on days 1-3. Treatment continues every 3 weeks for 2 courses in the absence of unacceptable toxicity. Patients undergo amputation or limb-sparing wide excision, as feasible, approximately 4 weeks after the second course. If surgery cannot be scheduled at this time for logistical reasons, a third course may be administered. Patients with an estimated tumor kill of at least 50% receive adjuvant chemotherapy as outlined below. Patients undergoing limb-sparing wide excision receive post-operative radiotherapy as outlined below. Adjuvant chemotherapy: Beginning 3-4 weeks after surgery, patients receive cisplatin IV over 4 hours on day 1 and doxorubicin as above on days 1-3. Treatment continues every 3 weeks for 4 courses in the absence of disease progression, stable disease, or unacceptable toxicity. Patients undergoing radiotherapy receive the final 3 courses of chemotherapy after completion of radiotherapy. Post-operative radiotherapy: Beginning after the first postoperative chemotherapy course and within 8 weeks after surgery, patients receive radiotherapy 5 days a week for 7-8 weeks. An interstitial implant using iridium Ir 192 may be used to administer the final doses of radiotherapy.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||CLINICAL AND PHARMACOLOGICAL STUDY OF CHEMOTHERAPY IN SOFT TISSUE SARCOMA|
|Study Start Date :||November 1991|
|Actual Primary Completion Date :||February 2000|
|Actual Study Completion Date :||February 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002492
|United States, Florida|
|Sylvester Cancer Center, University of Miami|
|Miami, Florida, United States, 33136|
|Study Chair:||Pasquale W. Benedetto, MD||University of Miami Sylvester Comprehensive Cancer Center|