Attribution of Toxicities Due to Radiotherapy and Immuno-Biological Therapies
- Conditions
- CancerRadiotherapy Side Effect
- Interventions
- Radiation: Radiotherapy
- Registration Number
- NCT04115267
- Lead Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3600
- 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.
• Refusal or inability to receive radiotherapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Combined modality Radiotherapy Patients receiving radiotherapy and a molecular agent for the treatment of cancer
- Primary Outcome Measures
Name Time Method Number of Participants with severe side effects 1 year CTCAE V5 Grade 3-5 toxicities
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centre Hospitalier de l'Université de Montréal
🇨🇦Montreal, Quebec, Canada