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NCT02565498Active, not recruitingPhase 3

Preoperative vs Postoperative IMRT for Extremity/Truncal STS

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

Source: ClinicalTrials.gov · Last updated 20 Feb 2024

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
210 (actual)
First submitted
18 Sept 2015
Start date
Jun 2016
Primary completion date
Oct 2024
Lead sponsor
Mount Sinai Hospital, Canada
Diseases
Sarcoma
NCT number
NCT02565498

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 210
  • From Jun 2016 to the primary completion date, Oct 2024
  • 8 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior radiotherapy to the target site
  • Planned chemotherapy for (neo)adjuvant treatment
  • Conservative surgery to the target site

Other illness

  • 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.
  • 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.

Other

  • Benign histology.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cliniques universitaires Saint-Luc
Coordinator of this site? Confirm its status
BrusselsBelgiumUnknown status
Hôpital Maisonneuve-Rosemont
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
The Ottawa Hospital Cancer Centre
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status
Princess Margaret Cancer Centre
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Mount Sinai Hospital
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Cleveland Clinic Taussig Cancer Institute
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Oregon Health Science University
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.