Attribution of Toxicities Due to Radiotherapy and Immuno-Biological Therapies

NCT ID: NCT04115267

Last Updated: 2024-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-13

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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Cancer Radiotherapy Side Effect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Combined modality

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

Radiotherapy

Intervention Type RADIATION

Combined modality

Interventions

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Radiotherapy

Combined modality

Intervention Type RADIATION

Other Intervention Names

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Anti-neoplastic Molecular Agent

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip Wong, MD

Role: PRINCIPAL_INVESTIGATOR

CHUM

Locations

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Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Mom Phat, RN

Role: CONTACT

1-514-8908000 ext. 11171

Facility Contacts

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Mom Phat, RN

Role: primary

514-8908000 ext. 11171

Other Identifiers

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19.065

Identifier Type: -

Identifier Source: org_study_id

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