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

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) (Other)
Overall Status
Recruiting
CT.gov ID
NCT04115267
Collaborator
(none)
3,600
1
72.6
49.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
3600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Attribution of Toxicities Due to Radiotherapy and Immuno-Biological Therapies - Registry
Actual Study Start Date :
Sep 13, 2019
Anticipated Primary Completion Date :
Sep 30, 2025
Anticipated Study Completion Date :
Sep 30, 2025

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with severe side effects [1 year]

      CTCAE V5 Grade 3-5 toxicities

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier de l'Université de Montréal Montreal Quebec Canada H2X 0A9

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Philip Wong, MD, CHUM

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre hospitalier de l'Université de Montréal (CHUM)
    ClinicalTrials.gov Identifier:
    NCT04115267
    Other Study ID Numbers:
    • 19.065
    First Posted:
    Oct 4, 2019
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 15, 2022