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ACTIVE NOT RECRUITING
NCT02565498
PHASE3

Preoperative vs Postoperative IMRT for Extremity/Truncal STS

Sponsor: Mount Sinai Hospital, Canada

View on ClinicalTrials.gov

Summary

This study is designed to determine if preoperative image guided radiation therapy (IGRT) delivered using intensity modulated radiation therapy (IMRT) followed by surgery results in similar short-term wound healing complications as surgery followed by postoperative IGRT in patients with extremity or truncal soft tissue sarcoma. Half of the patients will receive preoperative radiotherapy, half will receive postoperative radiotherapy.

Official title: Phase III Study of Preoperative vs Postoperative Intensity Modulated Radiation Therapy For Truncal/Extremity Soft Tissue Sarcoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2016-06

Completion Date

2029-05

Last Updated

2024-02-20

Healthy Volunteers

No

Interventions

RADIATION

Preoperative intensity modulated radiation therapy

50 Gy delivered in 25 fractions 4-6 weeks prior to surgical excision

RADIATION

Postoperative intensity modulated radiation therapy

Surgery followed by 50 Gy delivered in 25 fractions within 6 weeks of surgery for patients with negative margins; for patients with positive margins a boost of 16 Gy in 8 fractions will be added.

Locations (8)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Cleveland Clinic Taussig Cancer Institute

Cleveland, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Cliniques Universitaires Saint-Luc

Brussels, Belgium

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada