Prophylactic Cranial Irradiation (PCI) Versus Observation in Radically Treated Patients With Stage III Non-small Cell Lung Cancer; A Phase III Randomized Study.
18 Years
N/A
Both
Non Small Cell Lung Cancer (NSCLC), Radical Treatment, Stage III Non-Small Cell Lung Cancer
Trial Information
Prophylactic Cranial Irradiation (PCI) Versus Observation in Radically Treated Patients With Stage III Non-small Cell Lung Cancer; A Phase III Randomized Study.
For this group of patients, brain metastases are one of the major sites of tumor failure.
Radical therapy of symptomatic brain metastases is seldom possible and only very rarely,
long term survival can be achieved. PCI has shown to reduce the incidence of brain
metastases in patients with non-small cell lung cancer to the same extent as in limited
disease small-cell lung cancer. However, the exact value of PCI in stage III NSCLC patient,
treated with contemporary chemo-radiation schedule with or without surgery, remains
unsettled. Therefore this study is launched, in order to investigate whether PCI should
become the standard of care in patients with stage III NSCLC who are treated with curative
intention.
Inclusion Criteria:
- UICC stage IIIA or IIIB (without malignant pleural of pericardial effusion) non-small
cell lung cancer (histology or cytology)
- Whole body FDG-PET-scan before start of therapy available: No distant metastases
- CT or MRI of the brain before the start of radical therapy available: No brain
metastases
- Platinum-based chemotherapy is mandatory
- Radical local therapy: concurrent of sequential chemotherapy (platinum-based) and
radiotherapy with or without surgery
- Radiotherapy dose without surgery at least a biological equivalent of 60Gy
- No prior cranial irradiation
- Patients must sign a study-specific informed consent at the time of registration
Exclusion Criteria:
- The opposite of the above
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Proportion of patients developing symptomatic brain metastasis
Outcome Time Frame:
24 months after randomisation
Safety Issue:
No
Principal Investigator
Dirk De Ruysscher, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
NVALT oncology foundation
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
NVALT11
NCT ID:
NCT01282437
Start Date:
January 2009
Completion Date:
January 2014
Related Keywords:
- Non Small Cell Lung Cancer (NSCLC)
- Radical Treatment
- Stage III Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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