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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Maastricht Radiation Oncology
Sponsor:
Collaborators:
The Netherlands Cancer Institute
VU University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Maastricht University Medical Center
University Medical Centre Groningen
Information provided by (Responsible Party):
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT01290809
First received: February 1, 2011
Last updated: September 16, 2013
Last verified: September 2013

February 1, 2011
September 16, 2013
January 2011
January 2014   (final data collection date for primary outcome measure)
cognitive sequelae [ Time Frame: 36 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01290809 on ClinicalTrials.gov Archive Site
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Prophylactic Cranial Irradiation (PCI) Cognitive Tests in Non-small Cell Lung Cancer (NSCLC) Patients
Cognitive Sequelae of Prophylactic Cranial Irradiation in Non-small Cell Lung Cancer Patients

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.

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Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
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Probability Sample

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).

NSCLC
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  • 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?
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
170
January 2014
January 2014   (final data collection date for primary outcome measure)

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:

  • none
Both
18 Years and older
No
Contact: Dirk De Ruysscher +31 884455666 dirk.deruysscher@maastro.nl
Contact: Brigitta Baumert +31 884455666 brigitta.baumert@maastro.nl
Netherlands
 
NCT01290809
093074
Yes
Maastricht Radiation Oncology
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 Centre Groningen
Principal Investigator: Dirk deruysscher Maastro Clinic, The Netherlands
Maastricht Radiation Oncology
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP