IMRT Lower Limb Soft Tissue Sarcoma

NCT ID: NCT00188175

Last Updated: 2014-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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IMRT for lower limb soft tissue sarcoma

Group Type EXPERIMENTAL

Intensity Modulated Radiation Therapy

Intervention Type RADIATION

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

Interventions

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Intensity Modulated Radiation Therapy

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ontario Cancer Research Network

NETWORK

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian O'Sullivan, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

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Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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UHN REB 03-0107-C

Identifier Type: -

Identifier Source: org_study_id

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