Pre-operative RadiothErapy for Soft Tissue SarcOmas

NCT04617327 | Active Not Recruiting DMC

• 1 other identifier: MUHC-RIMUHC
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Soft tissue sarcomas (STSs) are malignant tumours that arise in any of the mesodermal tissues in the body including muscles, fibrous tissues, bone and cartilage, adipose tissue, and blood vessels, most frequently in the extremities (40%), trunk and retroperitoneum (40%). Traditionally, the prescription schedule for conventional preoperative RT is a regimen of 50 Gy in fractions of 1.8-2 Gy per day. Concerns regarding this regimen include the delay to definitive surgery and the higher rate of wound complications compared to post-operative radiotherapy. Hypofractionated RT is a prescription schedule in which the total dose of radiation is delivered in larger doses per fraction in fewer fractions allowing the delivery of a higher biologically effective dose (BED) to the tumour than with conventional RT \[7\] during a shorter period of time.

Conditions

Soft Tissue Sarcoma Adult

Outcome Measures

Primary Outcomes (1)

• Acute RadiationToxicity using Common Terminology Criteria for Adverse Events (CTCAE) V.5

  To assess, skin reactions and wound healing

  1 month

Secondary Outcomes (1)

• Physicians Muscle Tumor Rating Scale

  1 year

Study Arms (1)

Experimental : Short Course Pre-operative RadiothErapy

EXPERIMENTAL

As part of the planning process, you need to undergo a CT Simulation.It is special type of CT scan used to measure and design the radiation fields to precisely target the tumor.It is done at the Radiation Oncology Department at the MUHC. Some patients may be asked to also undergo an MRI Simulation, and the CT simulation. You may asked to provide a blood sample to ensure good kidney function prior to the CT and MRI scans. Both CT and MRI simulations are considered standard of care. Once the simulation studies are done, there is about a 2 week waiting period for radiation planning prior to starting the radiation treatments. The hypofractionation technique will be delivering five fractions (one fraction delivered every 2nd day) of 7 Gy daily of external beam radiotherapy (EBRT) over a period of one and half weeks for a total of 35 Gy. The treatment should last approximately 30 minutes. Once treatments are done, there is a 4 to 6 week wait for surgery.

Radiation: Hypofractionation

Interventions

Hypofractionation RADIATION

Shorter radiation therapy means that a higher dose will be given on a daily basis. The goal is to target microscopic disease and decrease the chances of local recurrence. Organs at risk (OAR) will receive doses following the constraints from the Timmerman tables used for reference when using 5 or more fractions of EBRT. Treatment will be delivered every 2nd day, for a maximum of 3 fractions per week. Daily pretreatment Image Guided Radiotherapy Images (IGRT) (Cone-Beam CT - CBCT) will be co-registered with the CT simulation dataset to adjust patient position before each treatment by matching the bone adjacent to the planned tumour volume (PTV). Treatment will be administered if there is \<3 mm in any dimension, or rotation is \<3 degrees. If the isocentre set-up exceeds 3 mm at any given treatment session, the treatment couch will be translated to restore its planned position.

Also known as: Hypofractionated Radiation Therapy

Experimental : Short Course Pre-operative RadiothErapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven STS of the extremities, above the knee, or trunk following review by our pathologist
• Lesions smaller than 15cm in largest dimension
• Deemed appropriate for preoperative radiotherapy and conservative surgery following patient assessment by a radiation oncologist and surgical oncologist
• Lesion is primary or locally recurrent. Patients who underwent unplanned non-oncological excision ("whoops" procedure) at a referring hospital are NOT eligible
• No previous radiation therapy
• ECOG 0-2 (or Karnofsky Performance Status ≥ 70) within 60 days prior to registration
• Resectable primary lesion with or without distant metastasis
• Age ≥ 18
• Patient must be able to provide study-specific informed consent prior to study entry
• Patient is available for treatment and follow-up

You may not qualify if:

• Patients who underwent unplanned non-oncological excision ("whoops" procedure) at a referring hospital
• Lesions below the knee
• Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy, unless continually disease free for a minimum of 5 years
• Regional lymph node involvement
• Previous irradiation to the area to be treated
• Other major medical illness deemed to preclude safe administration of protocol treatment or required follow-up

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre-Cedars Cancer Centre

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Interventions

Radiation Dose Hypofractionation

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Fabio Cury, MD

  Research Institute of McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator/Radiation Oncologist

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: November 5, 2020
• Study Start: June 5, 2020
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

CA (1)