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This trial is a multicentric, prospective cohort study of 150 patients aiming to model evolution of toxicity over time in patients with solid tumor and starting first cycle of Immune Checkpoint Inhibitor (ICI) treatment.
The study will be conducted on a population of patients treated with ICI in the context of routine care. The follow-up during the treatment period and the clinical, biological and radiological assessments will be performed according to the standard of each centre.
The study data (immune-related adverse events) will be collected during each administration of the treatment.
A questionnaire will be completed by the patient before the treatment administrations.
Patients will be followed until disease progression or up to 12 months of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort of patients starting a treatment by ICI | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients starting a treatment by ICI | Other | Completion of the Quality of Life Questionnaire Core 30 (QLQ-C30) before treatment administration and during the 12 months of treatment period, at the following time points:
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of toxicities evaluated according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03 | 12 months by patient |
| Measure | Description | Time Frame |
|---|---|---|
| Time to appearance of toxicity | 12 months by patient | |
| Rate of patients for which treatment was restarted among those who had stopped treatment for the management of an immune-related Adverse Event (irAE) | 12 months by patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH ALBI | Albi | France | ||||
| Ch Castres |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32383099 | Background | Cabarrou B, Gomez-Roca C, Viala M, Rabeau A, Paulon R, Loirat D, Munsch N, Delord JP, Filleron T. Modernizing adverse events analysis in oncology clinical trials using alternative approaches: rationale and design of the MOTIVATE trial. Invest New Drugs. 2020 Dec;38(6):1879-1887. doi: 10.1007/s10637-020-00938-x. Epub 2020 May 7. | |
| 39495388 |
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|
| Quality of life using the QLQ-C30 questionnaire | 12 months by patient |
| Castres |
| France |
| Institut Regional Du Cancer de Montpellier (Icm) | Montpellier | 34298 | France |
| Institut Curie | Paris | 75005 | France |
| Hopital Larrey | Toulouse | 31059 | France |
| Institut Universitaire Du Cancer de Toulouse - Oncopole | Toulouse | 31059 | France |
| Morisseau M, Gomez-Roca C, Viala M, Rabeau A, Loirat D, Munsch N, Thomas K, Pages C, Korakis I, Sibaud V, Delord JP, Filleron T, Cabarrou B. Modernizing the assessment and reporting of adverse events in oncology clinical trials using complementary statistical approaches: a case study of the MOTIVATE trial. Invest New Drugs. 2024 Dec;42(6):664-674. doi: 10.1007/s10637-024-01481-9. Epub 2024 Nov 4. |