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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
150
Prophylactic cranial irradiation (PCI): 25 Gy in 10 daily fractions, five times a week
Hippocampal avoidance prophylactic cranial irradiation 25 Gy in 10 daily fractions, five times a week
Hospital Del Mar. Radiation Oncology Department
Barcelona, Spain
Neurocognitive functioning (NCF) (Free and Cued Selective Reminding Test)
Free and Cued Selective Reminding Test (FCSRT) evaluated at baseline and 3 months after radiation
Time frame: Change from baseline to 3 months
Neurocognitive functioning (NCF) (Free and Cued Selective Reminding Test)
Free and Cued Selective Reminding Test (FCSRT) evaluated at baseline and 6,12 and 24 months after radiation
Time frame: Change from baseline to 6,12 and 24 months
Hippocampus brain metastases (brain magnetic resonance imaging) (MRI)
Evaluation of hippocampus brain metastases at 3, 6, 12 and 24 months after radiation
Time frame: Change from baseline to 3, 6,12 and 24 months
Hippocampus volume (brain magnetic resonance imaging) (MRI)
Evaluation of hippocampus volume at 3, 6, 12 and 24 months after radiation
Time frame: Change from baseline to 3, 6,12 and 24 months
Adverse effects (according to Common Toxicity Criteria for Adverse Effects)
Evaluation of adverse effects according to Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.0 at 3, 6, 12 and 24 months after radiation
Time frame: Change from baseline to 3, 6,12 and 24 months
Quality of life (measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire (QLQ C-30 and QLQ BN-20)
Evaluation of Quality of Life (QoL) measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire (QLQ C-30 and QLQ BN-20)
Time frame: Change from baseline to 3, 6,12 and 24 months
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Overall survival
From the start date of PCI until the date of death from any cause, or the last follow-up date whichever came first, assessed up to 60months"
Time frame: Up to 5 years