Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pre-operative RadiothErapy for Soft Tissue SarcOmas (PRESTO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04617327
Recruitment Status : Recruiting
First Posted : November 5, 2020
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Fabio Cury, McGill University Health Centre/Research Institute of the McGill University Health Centre

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 Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 5, 2020
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


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 Name: Hypofractionated Radiation Therapy




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


Secondary Outcome Measures :
  1. Physicians Muscle Tumor Rating Scale [ Time Frame: 1 year ]
    To assess the amount of difficulty performing activities, including motion, strength and stability



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Fabio Cury, MD 514-934-4400 fabio.cury@muhc.mcgill.ca

Locations
Layout table for location information
Canada, Quebec
McGill University Health Centre-Cedars Cancer Centre Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Fabio Cury, MD    514-934-4400    fabio.cury@muhc.mcgill.ca   
Principal Investigator: Fabio Cury, MD         
Sub-Investigator: Freeman Carolyn, MD         
Sub-Investigator: Turcotte Robert, MD         
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
Layout table for investigator information
Principal Investigator: Fabio Cury, MD Research Institute of McGill University Health Centre
Layout table for additonal information
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: November 5, 2020    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms