Pre-operative RadiothErapy for Soft Tissue SarcOmas

Soft Tissue Sarcoma Adult Clinical Trial

— PRESTO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04617327
• Other study ID #: MUHC-RIMUHC
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Fabio Cury, MD
• Phone: 514-934-4400
• Email: fabio.cury[@]muhc.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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%).

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2027
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma Adult

Intervention

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.

Locations

Country	Name	City	State
Canada	McGill University Health Centre-Cedars Cancer Centre	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute RadiationToxicity using Common Terminology Criteria for Adverse Events (CTCAE) V.5	To assess, skin reactions and wound healing	1 month
Secondary	Physicians Muscle Tumor Rating Scale	To assess the amount of difficulty performing activities, including motion, strength and stability	1 year