NCT00188175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 3, 2014

Status Verified

June 1, 2014

Enrollment Period

10 years

First QC Date

September 9, 2005

Last Update Submit

June 2, 2014

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

  • Major wound complications within 120 days following surgery

    120 days post-op

Secondary Outcomes (1)

  • Assess acute and late radiation toxicity including limb edema

    up to120 days

Study Arms (1)

IMRT for lower limb soft tissue sarcoma

EXPERIMENTAL
Radiation: Intensity Modulated Radiation Therapy

Interventions

Intensity Modulated Radiation TherapyRADIATION

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

IMRT for lower limb soft tissue sarcoma

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Benign histologies
  • Histologies generally treated with chemotherapy
  • Prior or recurrent cancer, except nonmelanomatous skin cancer or carcinoma in-situ of the cervix

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Brian O'Sullivan, MD

    Princess Margaret Hospital, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

May 1, 2003

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

June 3, 2014

Record last verified: 2014-06

Locations

CA(1)