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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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

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Small Cell Lung Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Prophylactic cranial irradiation (PCI)

Radiation. Prophylactic cranial irradiation : 25 Gy in 10 daily fractions, five times a week

Group Type ACTIVE_COMPARATOR

Prophylactic cranial irradiation (PCI)

Intervention Type RADIATION

Prophylactic cranial irradiation (PCI): 25 Gy in 10 daily fractions, five times a week

Hippocampal avoidance PCI

Hippocampal avoidance prophylactic cranial irradiation. 25 Gy in 10 daily fractions, five times a week

Group Type EXPERIMENTAL

Hippocampal avoidance PCI

Intervention Type RADIATION

Hippocampal avoidance prophylactic cranial irradiation 25 Gy in 10 daily fractions, five times a week

Interventions

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Prophylactic cranial irradiation (PCI)

Prophylactic cranial irradiation (PCI): 25 Gy in 10 daily fractions, five times a week

Intervention Type RADIATION

Hippocampal avoidance PCI

Hippocampal avoidance prophylactic cranial irradiation 25 Gy in 10 daily fractions, five times a week

Intervention Type RADIATION

Eligibility Criteria

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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