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

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ClinicalTrials.gov Identifier: NCT01290809
Recruitment Status : Completed
First Posted : February 7, 2011
Last Update Posted : October 14, 2015
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease

Study Design

Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Cognitive Sequelae of Prophylactic Cranial Irradiation in Non-small Cell Lung Cancer Patients
Study Start Date : January 2011
Primary Completion Date : March 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Groups and Cohorts

Prophylactic Cranial Irradiation
NSCLC patients treated with whole brain PCI: cognitive functioning as assessed by neuropsychological tests?
no Prophylactic Cranial Irradiation
NSCLC patients not treated with whole brain PCI: cognitive functioning as assessed by neuropsychological tests?

Outcome Measures

Primary Outcome Measures :
  1. cognitive sequelae [ Time Frame: 36 months ]
    The proposed study will investigate the cognitive sequelae of PCI in NSCLC patients in the context of a phase III randomized trial (Nederlandse vereniging van artsen voor longziekten en tuberculose: NVALT-11) on the efficacy of PCI in decreasing the proportion of NSCLC patients developing brain metastasis, and the impact of PCI on neurological symptoms and health-related quality of life.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients will be recruited from 5 hospitals participating in the phase III trial: Prophylactic Cranial Irradiation (PCI) versus observation in radically treated patients with stage III non-small lung cancer: a phase III randomized study ((NVALT 11/DLCRG-02).

Inclusion Criteria:

  • UICC stage III A or III B (without malignant pleural or pericardial effusion) non-small cell lung cancer
  • Whole body PDG-PET scan before the start of therapy available: no distant metastasis.
  • CT or preferably MRI of the brain before the start of radical therapy available; no brain metastasis.
  • Platinum-based chemotherapy is mandatory.
  • Radical local therapy: concurrent or sequential chemotherapy and radiotherapy with or without surgery.
  • Radiotherapy dose without surgery to at least biological equivalent of 60 Gy.
  • No prior cranial irradiation.sufficient proficiency in Dutch language
  • sufficient proficiency in Dutch language
  • MRI (and not CT scan) pre-PCI

Exclusion Criteria:

Contacts and Locations

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): NCT01290809

Academic Medical Center
Amsterdam, Netherlands
Amsterdam, Netherlands
VU University Medical Center
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Sponsors and Collaborators
Maastricht Radiation Oncology
The Netherlands Cancer Institute
VU University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Maastricht University Medical Center
University Medical Center Groningen
Principal Investigator: Dirk deruysscher Maastro Clinic, The Netherlands
More Information

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01290809     History of Changes
Other Study ID Numbers: 093074
First Posted: February 7, 2011    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015

Keywords provided by Maastricht Radiation Oncology:
Prophylactic Cranial Irradiation
lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms