NCT04790253

PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population.

Detailed description

The primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population under the treatment policy strategy. The secondary objectives are: * To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of cognitive failure free survival (CFFS) compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population. * To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of global health status/QoL and cognitive functioning according to EORTC QLQ-C30 questionnaire compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population. * To evaluate the frequency and severity of toxicities according to CTCAE v5.0 in the two arms in the treated population (i.e. patients who have started treatment). The exploratory objectives are: * To compare OS and CFFS between the arms within the subgroups of patients with LS and ES disease. * To compare OS and CFFS between the arms within the subgroups: HA-PCI or not, first-line immunotherapy or not, memantine or not. * To compare cognitive failure free survival (CFFS) rate at 12 months after randomization between the arms. * To compare the cumulative incidence of cognitive failures with death as a competing risk between the arms. * To compare brain-metastasis-free survival (BMFS) between the arms. * To compare progression free survival (PFS) between the arms. * To compare time to brain-metastasis-attributed death (TBMAD) between the arms. * To compare other QoL scales according to EORTC QLQ-C30 and QLQ-BN20 questionnaires between arms. * To evaluate the cost-effectiveness of MRI surveillance alone versus MRI surveillance combined with PCI. * To collect blood for biobanking.

Conditions

• Limited Stage Small Cell Lung Cancer
• Extensive-stage Small-cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	Prophylactic cranial irradiation	Prophylactic cranial irradiation (PCI) is a technique used to combat the occurrence of metastasis to the brain in highly aggressive cancers that commonly metastasize to brain, most notably small-cell lung cancer.

Timeline

• Start date: 2022-10-27
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2021-03-10
• Last updated: 2023-11-03

Locations

41 sites across 9 countries: Austria, Belgium, France, Germany, Italy, Poland, Spain, Switzerland, United Kingdom