NCT02397733

Memory Preservation of Prophylactic Cranial Irradiation With Hippocampal Avoidance (PREMER-TRIAL)

Phase III Trial Evaluating Memory Preservation of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in Small Cell LUNG Cancer (PREMER-TRIAL)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Grupo de Investigación Clínica en Oncología Radioterapia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study i sto evaluate the impact of prophylactic cranial irradiation (PCI) with hippocampal avoidance in the neurocognitive function and quality of life of small cell lung cancer patients. In addition, the trial assesses the potential changes in hippocampal volumetry due to cranial irradiation using magnetic resonance imaging.

Detailed description

Prophylactic cranial irradiation (PCI) has become a standard of care for selected patients with limited and extensive stage small cell lung cancer (SCLC) who have shown benefit after chemotherapy with or without thoracic radiotherapy. Because hippocampal involvement by metastatic disease is rare, and because preclinical and clinical evidence suggests that radiation dose received by the hippocampus during whole brain radiotherapy may play a role in radiation-induced neurocognitive decline, sparing of the hippocampus during the administration of PCI should result in lower rates of memory loss. Previous studies have demonstrated the dosimetric capabilities of intensity modulated radiation therapy (IMRT) to conformably avoid the hippocampus without detriment to the radiation dose the remaining brain receives. The main objective of this trial is compare neurocognitive functioning following hippocampal avoidance PCI to standard PCI treatment measured by Free and Cued Selective Reminding Test (FCSRT). The FCSRT measures verbal learning and memory. The FCSRT emphasizes encoding specificity during learning and recall. One of the secondary objectives of this trial is to test the hypothesis that the lowered neurocognitive function of the patients is due to a substantial reduction in hippocampal volume in magnetic resonance imaging (MRI). Others objectives are to evaluate quality of life (QoL) and the rate of metastases in the hippocampus.

Conditions

• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
RADIATION	Prophylactic cranial irradiation (PCI)	Prophylactic cranial irradiation (PCI): 25 Gy in 10 daily fractions, five times a week
RADIATION	Hippocampal avoidance PCI	Hippocampal avoidance prophylactic cranial irradiation 25 Gy in 10 daily fractions, five times a week

Timeline

• Start date: 2014-09-01
• Primary completion: 2019-10-01
• Completion: 2020-12-01
• First posted: 2015-03-25
• Last updated: 2021-08-02

Locations

1 site across 1 country: Spain