Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Stage IB, Stage II, or Stage III Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT00740597|
Recruitment Status : Terminated (No patients were enrolled on the study)
First Posted : August 25, 2008
Results First Posted : July 11, 2014
Last Update Posted : July 11, 2014
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying the side effects of intensity-modulated radiation therapy and to see how well it works in treating patients undergoing surgery for stage IB, stage II, or stage III soft tissue sarcoma.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Genetic: gene expression analysis Genetic: polymerase chain reaction Genetic: western blotting Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Radiation: intensity-modulated radiation therapy||Phase 2|
- Estimate the wound complication rate in patients with stage IB-III soft tissue sarcoma (STS) treated with neoadjuvant intensity-modulated radiotherapy (IMRT).
- Assess local control rate in patients treated with this regimen.
- Assess metastatic failure rate in patients treated with this regimen.
- Assess disease-free survival of patients treated with this regimen.
- Assess overall survival of patients treated with this regimen.
- Assess function and general health in these patients using the Musculoskeletal Tumor Society rating scale, Toronto Extremity Salvage Score, and the Short-Form 36.
- Determine changes in STS gene expression after IMRT by microarray analyses.
- Correlate, preliminarily, changes in STS gene expression with pathological and clinical outcomes.
OUTLINE: Patients undergo intensity-modulated radiotherapy (IMRT) once daily 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery > 1 month after completion of IMRT.
Tumor tissue samples are collected at baseline and at the time of surgery for correlative laboratory studies. Samples are analyzed for gene expression by RNA microarray, real-time polymerase chain reaction, and western blotting.
After completion of study treatment, patients are followed periodically for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Preoperative Intensity-Modulated Radiation Therapy for Soft-Tissue Sarcomas|
|Study Start Date :||July 2008|
|Primary Completion Date :||April 2010|
|Study Completion Date :||April 2010|
Experimental: Arm 1
pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
|Genetic: gene expression analysis Genetic: polymerase chain reaction Genetic: western blotting Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Radiation: intensity-modulated radiation therapy|
- Wound Complication Rate [ Time Frame: 1 year ]
Major wound complications up to 4 months post surgery include:
Complications requiring a secondary operation under general or regional anesthesia for wound care.
Seroma aspiration. Drain placement. Minor wound debridement and wound care. Readmission for wound care such as intravenous antibiotics. Persistent wound deep packing or wound vacuum assisted closure for greater than 120 days.
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): NCT00740597
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Richard D. Pezner, MD||City of Hope Comprehensive Cancer Center|