Prophylactic Cranial Irradiation (PCI) Cognitive Tests in Non-small Cell Lung Cancer (NSCLC) Patients

NCT01290809 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2015-10-14

No results posted yet for this study

Summary

Stage III non-small cell lung cancer (NSCLC) patients constitute a significant proportion of the lung cancer population. The prognosis of these patients has improved over the years due the introduction of combined modality treatment, including high-dose chemo-radiotherapy. The brain, however, remains one of the major sites of failure. Patients with brain metastasis suffer from a variety of neurological, cognitive and emotional difficulties that are known to adversely affect the health-related quality of life. Prophylactic Cranial Irradiation (PCI) can prevent or delay the development of brain metastasis, and as such can improve neurological disease-free survival and consequently health-related quality of life. But survival is short, and toxicities are real, as PCI in itself can also induce adverse effects. The cognitive adverse effects of PCI are not sufficiently illuminated and documented, due to the lack of formal and systematic evaluation in patient populations expected to have short survival. Also, recent attempts to reduce cognitive side effects of PCI by the application of hippocampal-avoidance PCI in order to prevent memory deficits have not been fully evaluated yet.

Before PCI can be offered routinely to stage III NSCLC patients in daily practice, the costs and benefits of this therapy should be investigated properly, to allow for well-informed treatment choices.

Conditions

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    collaborator OTHER
  • Amsterdam UMC, location VUmc

    collaborator OTHER
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER
  • Maastricht University Medical Center

    collaborator OTHER
  • University Medical Center Groningen

    collaborator OTHER
  • Maastricht Radiation Oncology

    lead OTHER

Principal Investigators

  • Dirk deruysscher · Maastro Clinic, The Netherlands

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-03-31
Completion
2015-10-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01290809 on ClinicalTrials.gov