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IMRT Lower Limb Soft Tissue Sarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00188175
First Posted: September 16, 2005
Last Update Posted: June 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ontario Cancer Research Network
Information provided by (Responsible Party):
University Health Network, Toronto
  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: None (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 ]

Secondary Outcome Measures:
  • Assess acute and late radiation toxicity including limb edema [ Time Frame: up to120 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00188175     History of Changes
Other Study ID Numbers: UHN REB 03-0107-C
First Submitted: September 9, 2005
First Posted: September 16, 2005
Last Update Posted: June 3, 2014
Last Verified: June 2014

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