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Chemotherapy, Irradiation, and Surgery for Function-Preserving Curative Therapy of Primary Extremity Soft Tissue Sarcomas: Initial Treatment With I-MAP and GM-CSF; Aerosol GM-CSF During Preoperative Irradiation and Postoperatively
Sponsor study identifier
Secondary identifiers
interventional
39
0 countries
N/A
Study Start
August 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2006
Actual (reported)Study Completion
Not reported
Date not reportedRATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. GM-CSF may stimulate the immune system in different ways and stop tumor cells from growing. GM-CSF, given by inhalation, may interfere with the growth of tumor cells and prevent metastases from forming. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy and GM-CSF before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy and GM-CSF before and after surgery works in treating patients with stage III soft tissue sarcoma that can be removed by surgery.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2001
Date type not reportedThis date has not been verified as actual or estimated.
November 2006
Actual (reported)April 3, 2008
Actual (reported)April 4, 2008
Actual (reported)Pulmonary metastatic progression-free rate at 2 years
Survival
Time to progression
Toxicity as per NCI CTC Version 2.0
Tumor response every 4 weeks during treatment
Scott Okuno, MD
Mayo Clinic
First Submitted
April 3, 2008
First Posted
April 4, 2008
Study Start
August 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2006
Actual (reported)Contact the study team to confirm eligibility.
Last Updated
May 16, 2011
Record last verified: 2011-05
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Source: ClinicalTrials.gov.
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