Attribution of Toxicities Due to Radiotherapy and Immuno-Biological Therapies (AtTRIBut)

Attribution of Toxicities Due to Radiotherapy and Immuno-Biological Therapies - Registry

Every year, new molecular agents enter the market with more and more patients receiving these treatments, especially in the metastatic setting. These molecular agents could correspond to immunotherapy and modulators of signaling pathways. More than 50% of cancer patients will receive radiation therapy during the course of their illness, including radiotherapy aimed a palliating symptoms secondary to metastatic diseases. Therefore, there will be an increasing number of patients who will be receiving radiotherapy while they are still receiving molecular agents. A better understanding of the interaction of these two treatment modalities is needed.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Radiotherapy Side Effect
• Intervention / Treatment: Radiation: Radiotherapy

Detailed Description

Every year, new molecular agents enter the market with more and more patients receiving these treatments, especially in the metastatic setting. These molecular agents could correspond to immunotherapy and modulators of signaling pathways. More than 50% of cancer patients will receive radiation therapy during the course of their illness, including radiotherapy aimed a palliating symptoms secondary to metastatic diseases. Therefore, there will be an increasing number of patients who will be receiving radiotherapy while they are still receiving molecular agents. A better understanding of the interaction of these two treatment modalities is needed.

It is within this context that this registry was set up to gather information from physicians and patients treated with molecular agents and radiation therapy. The information being collected include diagnosis, doses received, type of targeted therapy, side effects, etc. Through this registry, we wish to determine whether there are more Grade 3 or above side effects than what is reported in the literature for these treatment modalities, when given alone or in combination. Participating patients will also describe their perceived side effects and quality of life.

• Study Type: Observational
• Enrollment (Estimated): 3600

Contacts and Locations

• Study Contact: Name: Mom Phat, RN; Phone Number: 11171 1-514-8908000; Email: mom.phat.chum@ssss.gouv.qc.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 0A9
      • Recruiting
      • Centre Hospitalier de l'Université de Montréal
      • Contact: Mom Phat, RN; Phone Number: 11171 514-8908000; Email: mom.phat.chum@ssss.gouv.qc.ca
      • Principal Investigator: Philip Wong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients planned to be treated with radiotherapy and who are receiving a targeted therapy, including immunotherapy.

Description

Inclusion Criteria:

• Consent to be part of the AtTRIBut registry
• Prior histological diagnosis of primary cancer.
• If the patient has metastatic disease, there must be radiological or pathological evidence of metastasis
• Age> 18 years
• Receiving a molecular therapy
• Indicated to receive radiotherapy
• Radiation therapy can be administered using 3D conventional, IMRT or SBRT techniques.

Exclusion Criteria:

• Refusal or inability to receive radiotherapy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Combined modality; Patients receiving radiotherapy and a molecular agent for the treatment of cancer	Radiation: Radiotherapy; Combined modality; Other Names: Anti-neoplastic Molecular Agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with severe side effects	CTCAE V5 Grade 3-5 toxicities	1 year

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Philip Wong, MD, CHUM

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2019
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Patient reported outcome; Cancer; Registry; Side effects; Combined effect
• Additional Relevant MeSH Terms: Antineoplastic Agents
• Other Study ID Numbers: 19.065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No