Attribution of Toxicities Due to Radiotherapy and Immuno-Biological Therapies

Cancer Clinical Trial

— AtTRIBut  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04115267
• Other study ID #: 19.065
• Status: Recruiting
• Start date: September 13, 2019
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Mom Phat, RN
• Phone: 1-514-8908000
• Email: mom.phat.chum[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3600
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Radiotherapy Side Effect

Intervention

Radiation:
• Radiotherapy
Combined modality

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with severe side effects	CTCAE V5 Grade 3-5 toxicities	1 year