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

Grupo de Investigación Clínica en Oncología Radioterapia

Status: Completed

Conditions: Small Cell Lung Carcinoma

Treatments: Radiation: Hippocampal avoidance PCI; Radiation: Prophylactic cranial irradiation (PCI)

Study type: Interventional

Funder types: Other

Identifiers

NCT02397733

PREMER-TRIAL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 2 patient groups

Prophylactic cranial irradiation (PCI)

Active Comparator group

Description:

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

Treatment:

Radiation: Prophylactic cranial irradiation (PCI)

Hippocampal avoidance PCI

Experimental group

Description:

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

Treatment:

Radiation: Hippocampal avoidance PCI