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: June 12, 2014
Last verified: June 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Preoperative Intensity-Modulated Radiation Therapy for Soft-Tissue Sarcomas

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Wound Complication Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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.



Enrollment: 1
Study Start Date: July 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740597

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Richard D. Pezner, MD Beckman Research Institute
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00740597     History of Changes
Other Study ID Numbers: 07216, P30CA033572, CHNMC-07216, CDR0000612344
Study First Received: August 22, 2008
Results First Received: June 12, 2014
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
recurrent adult soft tissue sarcoma
stage I adult soft tissue sarcoma
stage II adult soft tissue sarcoma
stage III adult soft tissue sarcoma
adult alveolar soft-part sarcoma
adult epithelioid sarcoma
adult extraskeletal chondrosarcoma
adult extraskeletal osteosarcoma
adult fibrosarcoma
adult malignant fibrous histiocytoma
adult malignant hemangiopericytoma
adult malignant mesenchymoma
adult neurofibrosarcoma
adult rhabdomyosarcoma
dermatofibrosarcoma protuberans

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014