Attribution of Toxicities Due to Radiotherapy and Immuno-Biological Therapies

NCT04115267 | Recruiting DMC

• 1 other identifier: 19.065
• Study Type: observational
• Target: 3,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Radiotherapy Side Effect

Keywords

Combined effect; Registry; Side effects; Patient reported outcome; Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants with severe side effects

  CTCAE V5 Grade 3-5 toxicities

  1 year

Study Arms (1)

Combined modality

Patients receiving radiotherapy and a molecular agent for the treatment of cancer

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

Combined modality

Also known as: Anti-neoplastic Molecular Agent

Combined modality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients planned to be treated with radiotherapy and who are receiving a targeted therapy, including immunotherapy.

You may qualify if:

• 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.

You may not qualify if:

• Refusal or inability to receive radiotherapy

Sponsors & Collaborators

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

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms; Radiation Injuries

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Philip Wong, MD

  CHUM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mom Phat, RN

CONTACT

1-514-8908000; mom.phat.chum@ssss.gouv.qc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: September 13, 2019
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)