NCT02906384

Memory and MRI Changes With Hippocampus Avoidance Prophylactic Cranial Irradiation(HA-PCI) for Small Cell Lung Cancer(SCLC)

Memory Preservation and Functional Brain Magnetic Resonance Imaging Changes With Conformal Avoidance of the Hippocampal Neural Stem-cell Compartment During Prophylactic Cranial Irradiation for Small Cell Lung Cancer Patients: A Prospective, Randomized Phase-II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized phase-II study observing the memory preservation and functional brain MRI changes with conformal avoidance of the hippocampal neural stem-cell compartment during prophylactic cranial irradiation for small cell lung cancer patients.

Detailed description

Brain metastasis is rather high in small cell lung cancer patients. Prophylactic cranial irradiation(PCI) is the standardized treatment. However, cognitive dysfunction like memory damage is observed in quite a number of patients after brain irradiation, which may due to the hippocampus being irradiated. Thus, the investigators conduct the study by reducing the dose to the hippocampal neural stem-cell compartment (HAZ) during PCI. Patient Population: Age: 18-65y; small cell lung cancer undergoing PCI; Eastern Cooperative Oncology Group (ECOG) score: 0-1. The patients are randomized to 2 arms: Arm Routine PCI: PTV(planning target volume) 25Gy/10F. Arm Hippocampus avoidance PCI(HA-PCI): PTV 25Gray(Gy)/10Fraction(F), HAZ Dmin\<9Gy Dmax\<16Gy). Measurements: Hopkins verbal learning test(HVLT) and functional brain magnetic resonance imaging.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	hippocampus avoidance	conformal avoidance of the hippocampal neural stem-cell compartment during prophylactic cranial irradiation

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-10-01
• Completion: 2020-10-01
• First posted: 2016-09-20
• Last updated: 2016-10-10

Locations

1 site across 1 country: China