Attribution of Toxicities Due to Radiotherapy and Immuno-Biological Therapies

Study Overview
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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.

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

Conditions
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Cancer, Radiotherapy Side Effect

Intervention / Treatment
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* Radiation: Radiotherapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Combined modality<br>Patients receiving radiotherapy and a molecular agent for the treatment of cancer | Radiation: Radiotherapy<br>* Combined modality<br>* Other names: Anti-neoplastic Molecular Agent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with severe side effects | CTCAE V5 Grade 3-5 toxicities | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Combined effect, Registry, Side effects, Patient reported outcome, Cancer