Clinical Trial: Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Stage IB, Stage II, or Stage III Soft Tissue Sarcoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase II Study of Preoperative Intensity-Modulated Radiation Therapy for Soft-Tissue Sarcomas

Brief Summary:

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.


Detailed Summary:

OBJECTIVES:

Primary

  • Estimate the wound complication rate in patients with stage IB-III soft tissue sarcoma (STS) treated with neoadjuvant intensity-modulated radiotherapy (IMRT).

Secondary

  • 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
Sponsor: City of Hope Medical Center

Current Primary Outcome: 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.



Original Primary Outcome: Wound Complication Rate

Current Secondary Outcome:

Original Secondary Outcome:

  • Local control rate
  • Metastatic failure rate
  • Disease-free survival
  • Overall survival
  • Function and general health as measured by the Musculoskeletal Tumor Society rating scale, Toronto Extremity Salvage Score, and the Short-Form 36
  • Changes in soft tissue sarcoma (STS) gene expression as measured by microarray analyses
  • Correlation of changes in STS gene expression with pathological and clinical outcomes


Information By: City of Hope Medical Center

Dates:
Date Received: August 22, 2008
Date Started: July 2008
Date Completion:
Last Updated: June 12, 2014
Last Verified: June 2014