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Clinical Trials/NCT04115267
NCT04115267
Recruiting
Not Applicable

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

Centre hospitalier de l'Université de Montréal (CHUM)1 site in 1 country3,600 target enrollmentSeptember 13, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Enrollment
3600
Locations
1
Primary Endpoint
Number of Participants with severe side effects
Status
Recruiting
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 13, 2019
End Date
September 30, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Number of Participants with severe side effects

Time Frame: 1 year

CTCAE V5 Grade 3-5 toxicities

Study Sites (1)

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