Pre-operative RadiothErapy for Soft Tissue SarcOmas (PRESTO)

Short Course Pre-operative RadiothErapy for Soft Tissue SarcOmas - a Phase I/II Trial (PRESTO)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Soft Tissue Sarcoma Adult
• Intervention / Treatment: Radiation: Hypofractionation

Detailed Description

This will be a phase I/II study of hypofractionation delivering five fractions (one fraction delivered every 2nd day) of 7 Gy of external beam radiotherapy over 5 fractions (one and half week period) in patients with localized STSs who are planned to receive pre-operative radiotherapy. Patients will undergo surgery 4-6 weeks after completion of RT.

Pre-treatment evaluation will be according to standard practice:

History and Physical Exam

• height,
• weight
• history (diabetes, vascular disease)

Radiology

• MRI of primary site or
• CT if MRI not tolerated
• CT chest

Quality of Life

• Musculoskeletal Tumour Society Rating Scale
• Toronto Extremity Salvage Score (TESS)

Follow-up assessment will be done as follows:

History and Physical Exam

• Acute radiation toxicity
• During RT and 2 weeks after end of RT

Acute surgical toxicity - wound assessment

• At hospital discharge,
• 2 weeks post-surgery
• 1 month post-surgery
• 3 months post-surgery
• 6 months post-surgery

Late toxicity (skin, subcutaneous, bone, joint) & peripheral limb edema

- Every 6 months thereafter

Radiology

• Chest CT-scan
• Within 1 month pre-surgery
• Standard thereafter

MRI or CT scan of primary site

• Prior to surgery, as standard
• Every 3-6 months or as needed after surgery

Quality of life Questionnaires

• Toronto Extremity Salvage Score (TESS
• Musclo Tumor Rating Scale (MSTS)
• At months 1,3,6, 12, 18 and 24 after surgery.
• Yearly thereafter up to 5 years

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre-Cedars Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental : Short Course Pre-operative RadiothErapy; 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; 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.; Other Names: Hypofractionated Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute RadiationToxicity using Common Terminology Criteria for Adverse Events (CTCAE) V.5	To assess, skin reactions and wound healing	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physicians Muscle Tumor Rating Scale	To assess the amount of difficulty performing activities, including motion, strength and stability	1 year

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Fabio Cury, MD, Research Institute of McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2020
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: October 30, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma
• Other Study ID Numbers: MUHC-RIMUHC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No