Cognitive Sequelae of Prophylactic Cranial Irradiation in Non-small Cell Lung Cancer Patients
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
NSCLC
Both
NSCLC
Trial Information
Cognitive Sequelae of Prophylactic Cranial Irradiation in Non-small Cell Lung Cancer Patients
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Crossover, Time Perspective: Prospective
Outcome Measure:
cognitive sequelae
Outcome Description:
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.
Outcome Time Frame:
36 months
Safety Issue:
No
Principal Investigator
Dirk deruysscher
Investigator Role:
Principal Investigator
Investigator Affiliation:
MAASTRO Clinic
Authority:
Netherlands: Medical Ethics Review Committee (METC)
Study ID:
093074
NCT ID:
NCT01290809
Start Date:
January 2011
Completion Date:
January 2013
Related Keywords:
- NSCLC
- Prophylactic Cranial Irradiation
- lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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