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Preoperative vs Postoperative IMRT for Extremity/Truncal STS

NCT02565498 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2024-02-20

No results posted yet for this study

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.

Conditions

  • Adult Soft Tissue Sarcoma

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.

Sponsors & Collaborators

  • Princess Margaret Hospital, Canada

    collaborator OTHER

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Peter Ferguson, MD, FRCSC · MOUNT SINAI HOSPITAL

  • Peter Chung, MD · Princess Margaret Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2024-10-31
Completion
2029-05-31

Countries

  • United States
  • Belgium
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02565498 on ClinicalTrials.gov