Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT04115267
Recruitment Status : Recruiting
First Posted : October 4, 2019
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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
Cancer Radiotherapy Side Effect 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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 3600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Attribution of Toxicities Due to Radiotherapy and Immuno-Biological Therapies - Registry
Actual Study Start Date : September 13, 2019
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : September 30, 2025

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




Primary Outcome Measures :
  1. Number of Participants with severe side effects [ Time Frame: 1 year ]
    CTCAE V5 Grade 3-5 toxicities



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
Sampling Method:   Non-Probability Sample
Study Population
Patients planned to be treated with radiotherapy and who are receiving a targeted therapy, including immunotherapy.
Criteria

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


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): NCT04115267


Contacts
Layout table for location contacts
Contact: Diane Trudel, RN 1-514-8908000 ext 11181 diane.dt.trudel.chum@ssss.gouv.qc.ca

Locations
Layout table for location information
Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Montreal, Quebec, Canada, H2X 0A9
Contact: Diane Trudel, RN    514-8908000 ext 11181    diane.dt.trudel.chum@ssss.gouv.qc.ca   
Principal Investigator: Philip Wong, MD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Layout table for investigator information
Principal Investigator: Philip Wong, MD CHUM
Layout table for additonal information
Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04115267    
Other Study ID Numbers: 19.065
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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):
Combined effect
Registry
Side effects
Patient reported outcome
Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Antineoplastic Agents