IMRT Lower Limb Soft Tissue Sarcoma

This study is currently recruiting participants.

Verified by University Health Network, Toronto, January 2008

First Received: September 9, 2005 Last Updated: January 24, 2008 History of Changes

Sponsors and Collaborators:	University Health Network, Toronto Ontario Cancer Research Network
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00188175

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 II

MedlinePlus related topics: Cancer Radiation Therapy Soft Tissue Sarcoma

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	60
Study Start Date:	May 2003
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Radiation	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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188175

Contacts

Contact: O'Sullivan Brian, MD

416-946-2125

brian.o'sullivan@rmp.uhn.on.ca

Locations

Canada, Ontario
Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Brian O'Sullivan, MD 416-946-2125 brian.o'sullivan@rmp.uhn.on.ca

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 ( Dr. Brian O'Sullivan, Principal Investigator )
Study ID Numbers:	03-0107-C
Study First Received:	September 9, 2005
Last Updated:	January 24, 2008
ClinicalTrials.gov Identifier:	NCT00188175 History of Changes
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Sarcoma

Additional relevant MeSH terms:

Neoplasms, Connective and Soft Tissue
Neoplasms
Neoplasms by Histologic Type
Sarcoma

ClinicalTrials.gov processed this record on May 07, 2009