Prophylactic Cranial Irradiation (PCI) Cognitive Tests in Non-small Cell Lung Cancer (NSCLC) 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.
|Study Design:||Observational Model: Case-Crossover
Time Perspective: Prospective
|Official Title:||Cognitive Sequelae of Prophylactic Cranial Irradiation in Non-small Cell Lung Cancer Patients|
- 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.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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?
Please refer to this study by its ClinicalTrials.gov identifier: NCT01290809
|Contact: Dirk De Ruysscher||+31 firstname.lastname@example.org|
|Contact: Brigitta Baumert||+31 email@example.com|
|Contact: Jose Belderbos firstname.lastname@example.org|
|Contact: Sanne Schagen email@example.com|
|Principal Investigator: J Belderbos|
|VU University Medical Center||Recruiting|
|Contact: F Lagerwaard|
|Contact: M Klein|
|Academic Medical Center||Recruiting|
|Contact: L Stalpers|
|Contact: A Uitterhoeve|
|University Medical Center Groningen||Recruiting|
|Contact: E Wiegman|
|Principal Investigator:||Dirk deruysscher||Maastro Clinic, The Netherlands|