Preoperative vs Postoperative IMRT for Extremity/Truncal STS

Running, not enrolling · Phase 3

Conditions studied: Adult Soft Tissue Sarcoma

In brief

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.

Key facts

Study ID

NCT02565498

Run by

Mount Sinai Hospital, Canada

People needed

210

Starts

2016-06-01

Expected to finish

2029-05-01

Last updated by the study team

2024-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven soft tissue sarcoma of the extremity or trunk following review by local reference pathologist.
• Deemed appropriate for preoperative or postoperative radiotherapy and conservative surgery following patient assessment by a radiation oncologist and surgical oncologist.
• Lesion is primary or locally recurrent. Patient may have undergone excisional biopsy with positive margins at a referring hospital and are eligible following discussion among the surgical oncologists and radiation oncologists that IMRT is an acceptable treatment for that case.
• Eastern Cooperative Oncology Group (ECOG) score 0-3
• Patient is aged 18years or older.
• Patient is able to provide informed consent
• Patient is available for treatment and follow-up.

You may not qualify if…

• Benign histology.
• Prior malignancy within the previous five years or concurrent malignancy with the exception of adequately treated basal cell carcinoma of the skin or carcinoma in-situ of the cervix.
• Prior radiotherapy to the target site
• Planned chemotherapy for (neo)adjuvant treatment
• Conservative surgery to the target site
• Presence of regional nodal disease or unequivocal distant metastases.
• Other major medical illness deemed to preclude safe administration of protocol treatment or required follow-up.

Where it is running

• 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

Full record on ClinicalTrials.gov

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