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| Name | Class |
|---|---|
| The Netherlands Cancer Institute | OTHER |
| Amsterdam UMC, location VUmc | OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| cognitive sequelae | 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. | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Dirk deruysscher | Maastro Clinic, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Amsterdam | Netherlands | ||||
| NKI |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Maastricht University Medical Center |
| OTHER |
| University Medical Center Groningen | OTHER |
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| Amsterdam |
| Netherlands |
| VU University Medical Center | Amsterdam | Netherlands |
| University Medical Center Groningen | Groningen | Netherlands |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |