IMRT Lower Limb Soft Tissue Sarcoma | NCT00188175

Studies
IMRT Lower Limb Soft Tissue Sarcoma

NCT00188175

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

Jun 3, 2014Estimated

Enrollment

59Actual

Phase

Phase 2

Conditions

Sarcoma

Interventions

Intensity Modulated Radiation Therapy

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2014

Last Update Posted Date

Jun 3, 2014Estimated

Name	Class
Ontario Cancer Research Network	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IMRT for lower limb soft tissue sarcoma	Experimental		Radiation: Intensity Modulated Radiation Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intensity Modulated Radiation Therapy	Radiation	Pre-op Intensity Modulated Radiation Therapy for lower limb soft tissue sarcoma.	IMRT for lower limb soft tissue sarcoma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major wound complications within 120 days following surgery		120 days post-op

Secondary Outcomes

Measure	Description	Time Frame
Assess acute and late radiation toxicity including limb edema		up to120 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brian O'Sullivan, MD	Princess Margaret Hospital, Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Princess Margaret Hospital		Toronto	Ontario	M5G 2M9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D012509	Sarcoma

Ancestor Terms

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050397	Radiotherapy, Intensity-Modulated

Ancestor Terms

ID	Term
D020266	Radiotherapy, Conformal
D011881	Radiotherapy, Computer-Assisted
D011878	Radiotherapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided