IMRT Lower Limb Soft Tissue Sarcoma

This study has been completed.
Sponsor:
Collaborator:
Ontario Cancer Research Network
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188175
First received: September 9, 2005
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

Intensity-modulated radiation therapy may make wound healing problems less likely by 1)precisely shaping the region of high radiation dose to the shape of the tissue which harbours tumour cells, and 2) precisely shaping the regions of low radiation dose to the shapes of the normal tissues which are more sensitive to radiation effects.


Condition Intervention Phase
Sarcoma
Radiation: Intensity Modulated Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II Study of Preoperative Intensity-Modulated Radiation Therapy For Lower Limb Soft Tissue Sarcoma

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Major wound complications within 120 days following surgery [ Time Frame: 120 days post-op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess acute and late radiation toxicity including limb edema [ Time Frame: up to120 days ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: May 2003
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMRT for lower limb soft tissue sarcoma Radiation: Intensity Modulated Radiation Therapy
Pre-op Intensity Modulated Radiation Therapy for lower limb soft tissue sarcoma.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven soft tissue sarcoma
  • Lesion lies between the iliac crest (hipbone) and the ankle
  • Lesion is newly diagnosed
  • Assessed by radiation oncologist and surgical oncologist

Exclusion Criteria:

  • Benign histologies
  • Histologies generally treated with chemotherapy
  • Prior or recurrent cancer, except nonmelanomatous skin cancer or carcinoma in-situ of the cervix
  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: NCT00188175

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Ontario Cancer Research Network
Investigators
Principal Investigator: Brian O'Sullivan, MD Princess Margaret Hospital, Canada
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00188175     History of Changes
Other Study ID Numbers: UHN REB 03-0107-C
Study First Received: September 9, 2005
Last Updated: June 2, 2014
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on October 21, 2014