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NCT Number: NCT04115267

Attribution of Toxicities Due to Radiotherapy and Immuno-Biological Therapies

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location status: Recruiting

Location contact

Mom Phat, RN

CONTACT

[email protected]

514-8908000 ext. 11171

Philip Wong, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

Combined modality

Other names: Anti-neoplastic Molecular Agent

Primary outcomes

  1. Number of Participants with severe side effects

    Time frame: 1 year

    CTCAE V5 Grade 3-5 toxicities

Study contacts

Contact information is provided by the study sponsor or research team.

Mom Phat, RN

CONTACT

[email protected]

1-514-8908000 ext. 11171

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Acronym: AtTRIBut

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Oct 4, 2019
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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