Evaluation of Technological Innovation in Radiotherapy

NCT03378856 | Recruiting

• 1 other identifier: 17.032
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 5

Brief Summary

Prospective cohort study of patients receiving standard-care radiotherapy is paramount to a better understanding of radiation effects and longterm outcomes. The primary objective is to determine the feasibility of establishing infrastructure to systematically collect clinical data, patient-reported outcomes, and imaging data from daily radiotherapy practice. Secondary objectives are to provide a control cohort for comparative effectiveness research of investigational interventions through a cmRCT design; compare imaging features with clinical outcomes; understand dose-effect relationships; quantify imaging quality metrics.

Conditions

Cancer; Radiotherapy Side Effect

Outcome Measures

Primary Outcomes (1)

• Accrual rates

  Determine feasibility of achieving high accural rates (greater than 80%) with this approach.

  2 years

Secondary Outcomes (1)

• Number of cmRCT trials activated

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving standard-care radiotherapy at CHUM

You may qualify if:

• Ability to provide informed consent
• Receiving radiotherapy or brachytherapy

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (5)

London Health Regional Cancer Centre

London, Ontario, Canada

NOT YET RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

NOT YET RECRUITING

Centre de santé et de services sociaux de Laval

Laval, Quebec, Canada

RECRUITING

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

RECRUITING

CHUQ

Québec, Quebec, Canada

NOT YET RECRUITING

Related Publications (3)

• Petit C, Delouya G, Taussky D, Barkati M, Lambert C, Beauchemin MC, Clavel S, Mok G, Pare AG, Nguyen TV, Duplan D, Keu KV, Saad F, Juneau D, Menard C. PSMA-PET/CT-Guided Intensification of Radiation Therapy for Prostate Cancer (PSMAgRT): Findings of Detection Rate, Effect on Cancer Management, and Early Toxicity From a Phase 2 Randomized Controlled Trial. Int J Radiat Oncol Biol Phys. 2023 Jul 15;116(4):779-787. doi: 10.1016/j.ijrobp.2022.12.055. Epub 2023 Jan 11.

  PMID: 36639035 DERIVED

• Belliveau C, Barkati M, Delouya G, Taussky D, Beauchemin MC, Lambert C, Beaulieu L, Beliveau-Nadeau D, Nicolas B, Carrier JF, Vigneault E, Menard C. Focal HDR brachytherapy boost to stereotactic radiotherapy (fBTsRT) for prostate cancer: a phase II randomized controlled trial. Radiat Oncol. 2022 Dec 9;17(1):203. doi: 10.1186/s13014-022-02173-5.

  PMID: 36494834 DERIVED

• Alley S, Jackson E, Olivie D, Van der Heide UA, Menard C, Kadoury S. Effect of magnetic resonance imaging pre-processing on the performance of model-based prostate tumor probability mapping. Phys Med Biol. 2022 Dec 13;67(24). doi: 10.1088/1361-6560/ac99b4.

  PMID: 36223780 DERIVED

MeSH Terms

Conditions

Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Cynthia Ménard, MD, M.Sc

CONTACT

514-890-8254; Cynthia.Menard@umontreal.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 20, 2017
• Study Start: November 1, 2017
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

CA (5)