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

This study has been terminated.
(No patients were enrolled on the study)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00740597
First received: August 22, 2008
Last updated: March 27, 2014
Last verified: March 2014

August 22, 2008
March 27, 2014
July 2008
April 2010   (final data collection date for primary outcome measure)
Wound complication rate [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00740597 on ClinicalTrials.gov Archive Site
  • Local control rate [ Designated as safety issue: No ]
  • Metastatic failure rate [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Function and general health as measured by the Musculoskeletal Tumor Society rating scale, Toronto Extremity Salvage Score, and the Short-Form 36 [ Designated as safety issue: No ]
  • Changes in soft tissue sarcoma (STS) gene expression as measured by microarray analyses [ Designated as safety issue: No ]
  • Correlation of changes in STS gene expression with pathological and clinical outcomes [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Stage IB, Stage II, or Stage III Soft Tissue Sarcoma
Phase II Study of Preoperative Intensity-Modulated Radiation Therapy for Soft-Tissue Sarcomas

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.

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 periodically for 2 years.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sarcoma
  • Genetic: gene expression analysis
  • Genetic: polymerase chain reaction
  • Genetic: western blotting
  • Procedure: neoadjuvant therapy
  • Procedure: therapeutic conventional surgery
  • Radiation: intensity-modulated radiation therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
April 2010
April 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed soft tissue sarcoma (STS) for which neoadjuvant or adjuvant radiotherapy is considered standard care

    • Stage IB-III disease
    • Primary or locally recurrent disease
  • The following chemotherapy-sensitive STS histologies are excluded:

    • Primitive neuroectodermal tumor
    • Desmoplastic small round cell tumor
    • Synovial sarcoma
    • Myxoid round cell liposarcoma
    • Angiosarcoma
  • No sarcomas for which surgical staging and adjuvant radiotherapy are considered standard care (e.g., uterine sarcomas, including leiomyosarcoma, malignant mixed Müllerian tumors, and endometrial stromal sarcoma)
  • No retroperitoneal STS

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Able to complete the self-assessment questionnaires (may use translator service)
  • Willing and able to undergo pre-treatment core needle biopsies
  • Negative pregnancy test
  • No known HIV positivity

PRIOR CONCURRENT THERAPY:

  • Prior adjuvant chemotherapy for STS allowed provided patient has locally recurrent disease

    • At least 1 year since prior adjuvant chemotherapy
  • No prior radiotherapy to the site of present STS
  • No other concurrent cytotoxic chemotherapy, targeted therapy, or investigational agents
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00740597
07216, P30CA033572, CHNMC-07216, CDR0000612344
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Richard D. Pezner, MD Beckman Research Institute
City of Hope Medical Center
March 2014

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