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Soft Tissue Sarcoma AdultPRESTONCT04617327

Pre-operative RadiothErapy for Soft Tissue SarcOmas

A study testing Hypofractionation in people with Soft Tissue Sarcoma Adult, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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%). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma Adult
What is being tested?
Hypofractionation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteCanada
Study dates
5 Jun 2020to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McGill University Health Centre-Cedars Cancer Centre

    Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

Official title: 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.

Read the 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
Being tested
Hypofractionation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HypofractionationRadiation

    Also called Hypofractionated Radiation Therapy

    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.

Study groups in NCT04617327
Study groupRoleWhat they receive
Experimental : Short Course Pre-operative RadiothErapyExperimentalAs 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.
Receives: Radiation: Hypofractionation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    To assess, skin reactions and wound healing

    Measured: 1 month

Secondary outcomes (1)

  1. Physicians Muscle Tumor Rating Scale

    To assess the amount of difficulty performing activities, including motion, strength and stability

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2020
  2. Study start5 Jun 2020
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04617327
Sponsor's protocol ID
MUHC-RIMUHC
Acronym
PRESTO
Status last verified
Jun 2025
First submitted
25 Jun 2020
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Hypofractionation in people with Soft Tissue Sarcoma Adult, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute RadiationToxicity using Common Terminology Criteria for Adverse Events (CTCAE) V.5 (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04617327.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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