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IMRT Lower Limb Soft Tissue Sarcoma

Primary Purpose

Sarcoma

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Intensity Modulated Radiation Therapy

About this trial

This is an interventional prevention trial for Sarcoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMRT for lower limb soft tissue sarcoma

Arm Description

Outcomes

Primary Outcome Measures

Major wound complications within 120 days following surgery

Secondary Outcome Measures

Assess acute and late radiation toxicity including limb edema

Full Information

NCT ID

NCT00188175

First Posted

September 9, 2005

Last Updated

June 2, 2014

Sponsor

University Health Network, Toronto

Collaborators

Ontario Cancer Research Network

1. Study Identification

Unique Protocol Identification Number

NCT00188175

Brief Title

IMRT Lower Limb Soft Tissue Sarcoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

May 2003 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

Collaborators

Ontario Cancer Research Network

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IMRT for lower limb soft tissue sarcoma

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

Intensity Modulated Radiation Therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Major wound complications within 120 days following surgery

Time Frame

120 days post-op

Secondary Outcome Measure Information:

Title

Assess acute and late radiation toxicity including limb edema

Time Frame

up to120 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian O'Sullivan, MD

Organizational Affiliation

Princess Margaret Hospital, Canada

Official's Role

Principal Investigator

Facility Information:

Facility Name

Princess Margaret Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

IMRT Lower Limb Soft Tissue Sarcoma

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