IMRT Lower Limb Soft Tissue Sarcoma

Sarcoma Clinical Trial

Official title:

A Phase II Study of Preoperative Intensity-Modulated Radiation Therapy For Lower Limb Soft Tissue Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188175
• Other study ID #: UHN REB 03-0107-C
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: June 2, 2014
• Start date: May 2003
• Est. completion date: May 2013

Study information

• Verified date: June 2014
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sarcoma

Intervention

Radiation:
• Intensity Modulated Radiation Therapy
Pre-op Intensity Modulated Radiation Therapy for lower limb soft tissue sarcoma.

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Ontario Cancer Research Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major wound complications within 120 days following surgery		120 days post-op	No
Secondary	Assess acute and late radiation toxicity including limb edema		up to120 days	No