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

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ClinicalTrials.gov Identifier: NCT02397733
Recruitment Status : Completed
First Posted : March 25, 2015
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Nuria Rodriguez de Dios, Grupo de Investigación Clínica en Oncología Radioterapia

Study Description
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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.


Condition or disease Intervention/treatment Phase
Small Cell Lung Carcinoma Radiation: Prophylactic cranial irradiation (PCI) Radiation: Hippocampal avoidance PCI Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Phase III Trial Evaluating Memory Preservation of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in Small Cell LUNG Cancer (PREMER-TRIAL)
Actual Study Start Date : September 2014
Actual Primary Completion Date : October 2019
Actual Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer Memory

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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"


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397733


Locations
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Spain
Hospital Del Mar. Radiation Oncology Department
Barcelona, Spain, 08009
Sponsors and Collaborators
Grupo de Investigación Clínica en Oncología Radioterapia
Investigators
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Study Chair: Núria Rodríguez de Dios, MD PhD +34683375231
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nuria Rodriguez de Dios, Principal Investigator, Grupo de Investigación Clínica en Oncología Radioterapia
ClinicalTrials.gov Identifier: NCT02397733    
Obsolete Identifiers: NCT02357875
Other Study ID Numbers: PREMER-TRIAL
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Additional relevant MeSH terms:
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Small Cell Lung Carcinoma
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms