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

July 27, 2021 updated by: Nuria Rodriguez de Dios, Grupo de Investigación Clínica en Oncología Radioterapia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08009
        • Hospital Del Mar. Radiation Oncology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prophylactic cranial irradiation (PCI)
Radiation. Prophylactic cranial irradiation : 25 Gy in 10 daily fractions, five times a week
Radiation: Prophylactic cranial irradiation (PCI)
Prophylactic cranial irradiation (PCI): 25 Gy in 10 daily fractions, five times a week
Experimental: Hippocampal avoidance PCI
Hippocampal avoidance prophylactic cranial irradiation. 25 Gy in 10 daily fractions, five times a week
Radiation: Hippocampal avoidance PCI
Hippocampal avoidance prophylactic cranial irradiation 25 Gy in 10 daily fractions, five times a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurocognitive functioning (NCF) (Free and Cued Selective Reminding Test)
Time Frame: Change from baseline to 3 months
Free and Cued Selective Reminding Test (FCSRT) evaluated at baseline and 3 months after radiation
Change from baseline to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurocognitive functioning (NCF) (Free and Cued Selective Reminding Test)
Time Frame: 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
Change from baseline to 6,12 and 24 months
Hippocampus brain metastases (brain magnetic resonance imaging) (MRI)
Time Frame: Change from baseline to 3, 6,12 and 24 months
Evaluation of hippocampus brain metastases at 3, 6, 12 and 24 months after radiation
Change from baseline to 3, 6,12 and 24 months
Hippocampus volume (brain magnetic resonance imaging) (MRI)
Time Frame: Change from baseline to 3, 6,12 and 24 months
Evaluation of hippocampus volume at 3, 6, 12 and 24 months after radiation
Change from baseline to 3, 6,12 and 24 months
Adverse effects (according to Common Toxicity Criteria for Adverse Effects)
Time Frame: 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
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)
Time Frame: 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)
Change from baseline to 3, 6,12 and 24 months
Overall survival
Time Frame: 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"
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo de Investigación Clínica en Oncología Radioterapia

Investigators

  • Study Chair: Núria Rodríguez de Dios, MD PhD, +34683375231

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

March 20, 2015

First Submitted That Met QC Criteria

March 20, 2015

First Posted (Estimate)

March 25, 2015

Study Record Updates

Last Update Posted (Actual)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREMER-TRIAL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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