Clinical trial NCT04115267: Attribution of Toxicities Due to Radiotherapy and Immuno-Biological Therapies
Official title: Attribution of Toxicities Due to Radiotherapy and Immuno-Biological Therapies - Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Radiotherapy Side Effect
Keywords: Combined effect
Registry
Side effects
Patient reported outcome
Cancer
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 3600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients planned to be treated with radiotherapy and who are receiving a targeted therapy, including immunotherapy.

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.

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

Primary outcomes:
measure: Number of Participants with severe side effects
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: CHUM
name: Philip Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: