Pre-operative RadiothErapy for Soft Tissue SarcOmas (PRESTO)
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|ClinicalTrials.gov Identifier: NCT04617327|
Recruitment Status : Recruiting
First Posted : November 5, 2020
Last Update Posted : November 5, 2020
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  during a shorter period of time.
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma Adult||Radiation: Hypofractionation||Not Applicable|
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
- history (diabetes, vascular disease)
- 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
- 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 (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Short Course Pre-operative RadiothErapy for Soft Tissue SarcOmas - a Phase I/II Trial (PRESTO)|
|Actual Study Start Date :||June 5, 2020|
|Estimated Primary Completion Date :||January 31, 2025|
|Estimated Study Completion Date :||December 31, 2027|
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.
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 Name: Hypofractionated Radiation Therapy
- Acute RadiationToxicity using Common Terminology Criteria for Adverse Events (CTCAE) V.5 [ Time Frame: 1 month ]To assess, skin reactions and wound healing
- Physicians Muscle Tumor Rating Scale [ Time Frame: 1 year ]To assess the amount of difficulty performing activities, including motion, strength and stability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04617327
|Contact: Fabio Cury, MDfirstname.lastname@example.org|
|McGill University Health Centre-Cedars Cancer Centre||Recruiting|
|Montréal, Quebec, Canada, H4A 3J1|
|Contact: Fabio Cury, MD 514-934-4400 email@example.com|
|Principal Investigator: Fabio Cury, MD|
|Sub-Investigator: Freeman Carolyn, MD|
|Sub-Investigator: Turcotte Robert, MD|
|Principal Investigator:||Fabio Cury, MD||Research Institute of McGill University Health Centre|