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

March 15, 2023 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

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

Intervention / Treatment

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 (Anticipated)

3600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 1 year
CTCAE V5 Grade 3-5 toxicities
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2019

Primary Completion (Anticipated)

September 30, 2025

Study Completion (Anticipated)

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)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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