PRESTO: Pre-operative RadiothErapy for Soft Tissue SarcOmas

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)

Overall Status

Recruiting

CT.gov ID

NCT04617327

Collaborator

(none)

Enrollment

Location

Arm

90.8

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Soft Tissue Sarcoma Adult	Radiation: Hypofractionation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 5, 2020

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Acute RadiationToxicity using Common Terminology Criteria for Adverse Events (CTCAE) V.5 [1 month]
To assess, skin reactions and wound healing

Secondary Outcome Measures

Physicians Muscle Tumor Rating Scale [1 year]
To assess the amount of difficulty performing activities, including motion, strength and stability

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McGill University Health Centre-Cedars Cancer Centre	Montréal	Quebec	Canada	H4A 3J1

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fabio Cury, Principal Investigator/Radiation Oncologist, McGill University Health Centre/Research Institute of the McGill University Health Centre

ClinicalTrials.gov Identifier:

NCT04617327

Other Study ID Numbers:

MUHC-RIMUHC

First Posted:

Nov 5, 2020

Last Update Posted:

Nov 5, 2020

Last Verified:

Oct 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sarcoma

Study Results

No Results Posted as of Nov 5, 2020