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

Not Applicable

Completed

• Conditions: Small Cell Lung Carcinoma
• Interventions: Radiation: Hippocampal avoidance PCI; Radiation: Prophylactic cranial irradiation (PCI)

• Registration Number: NCT02397733
• Lead Sponsor: Grupo de Investigación Clínica en Oncología Radioterapia

Brief 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-03-20
• Study First Submitted QC: 2015-03-20
• Study First Posted: 2015-03-25
• Primary Completion: 2019-10
• Study Completion: 2020-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• New diagnosed cytological or histologically confirmed Small cell lung carcinoma (stage I-IV) candidate for PCI, for example, without progressive disease after chemo-radiotherapy in stage I-III or after response after chemotherapy in stage IV
• Performance status ≤ 1
• Negative MRI of the brain within one month before protocol entry
• Patient must give written informed consent before registration

Exclusion Criteria

• Prior radiotherapy to the brain
• History of brain metastases
• Pregnancy or lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hippocampal avoidance PCI	Hippocampal avoidance PCI	Hippocampal avoidance prophylactic cranial irradiation. 25 Gy in 10 daily fractions, five times a week
Prophylactic cranial irradiation (PCI)	Prophylactic cranial irradiation (PCI)	Radiation. Prophylactic cranial irradiation : 25 Gy in 10 daily fractions, five times a week

Primary Outcome Measures

Name	Time	Method
Neurocognitive functioning (NCF) (Free and Cued Selective Reminding Test)	Change from baseline to 3 months	Free and Cued Selective Reminding Test (FCSRT) evaluated at baseline and 3 months after radiation

Secondary Outcome Measures

Name	Time	Method
Hippocampus volume (brain magnetic resonance imaging) (MRI)	Change from baseline to 3, 6,12 and 24 months	Evaluation of hippocampus volume at 3, 6, 12 and 24 months after radiation
Adverse effects (according to Common Toxicity Criteria for Adverse Effects)	Change from baseline to 3, 6,12 and 24 months	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
Overall survival	Up to 5 years	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"
Neurocognitive functioning (NCF) (Free and Cued Selective Reminding Test)	Change from baseline to 6,12 and 24 months	Free and Cued Selective Reminding Test (FCSRT) evaluated at baseline and 6,12 and 24 months after radiation
Quality of life (measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire (QLQ C-30 and QLQ BN-20)	Change from baseline to 3, 6,12 and 24 months	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)
Hippocampus brain metastases (brain magnetic resonance imaging) (MRI)	Change from baseline to 3, 6,12 and 24 months	Evaluation of hippocampus brain metastases at 3, 6, 12 and 24 months after radiation

Trial Locations

Locations (1)

Hospital Del Mar. Radiation Oncology Department; 🇪🇸 Barcelona, Spain