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

Small Cell Lung Carcinoma Clinical Trial

Official title:

Phase III Trial Evaluating Memory Preservation of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in Small Cell LUNG Cancer (PREMER-TRIAL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02397733
• Other study ID #: PREMER-TRIAL
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 2020

Study information

• Verified date: July 2021
• Source: Grupo de Investigación Clínica en Oncología Radioterapia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT02357875

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Small Cell Lung Carcinoma

Intervention

Radiation:
• Prophylactic cranial irradiation (PCI)
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

Locations

Country	Name	City	State
Spain	Hospital Del Mar. Radiation Oncology Department	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Grupo de Investigación Clínica en Oncología Radioterapia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive functioning (NCF) (Free and Cued Selective Reminding Test)	Free and Cued Selective Reminding Test (FCSRT) evaluated at baseline and 3 months after radiation	Change from baseline to 3 months
Secondary	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	Change from baseline to 6,12 and 24 months
Secondary	Hippocampus brain metastases (brain magnetic resonance imaging) (MRI)	Evaluation of hippocampus brain metastases at 3, 6, 12 and 24 months after radiation	Change from baseline to 3, 6,12 and 24 months
Secondary	Hippocampus volume (brain magnetic resonance imaging) (MRI)	Evaluation of hippocampus volume at 3, 6, 12 and 24 months after radiation	Change from baseline to 3, 6,12 and 24 months
Secondary	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	Change from baseline to 3, 6,12 and 24 months
Secondary	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)	Change from baseline to 3, 6,12 and 24 months
Secondary	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"	Up to 5 years