Prophylactic Cranial Irradiation (PCI) vs Observation in Stage III NSCLC

Study Overview
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Brief Summary
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For patients with stage III non-small cell lung cancer, which is radically treated, we will investigate whether prophylactic cranial irradiation (PCI) should become standard of care to prevent brain metastases.

Detailed Description
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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.

Official Title
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Prophylactic Cranial Irradiation (PCI) Versus Observation in Radically Treated Patients With Stage III Non-small Cell Lung Cancer; A Phase III Randomized Study.

Conditions
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Non Small Cell Lung Cancer (NSCLC), Radical Treatment, Stage III Non-Small Cell Lung Cancer

Intervention / Treatment
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* Radiation: Prophylactic Cranial Irradiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prophylactic Cranial Irradiation<br> | Radiation: Prophylactic Cranial Irradiation<br>* 18 fractions of 2Gy 12 fractions of 2.5Gy 10 fractions of 3 Gy<br>|
| No Intervention: Observation<br>Patients will not receive PCI, but will be observed and the same items will be measured as in the PCI-arm. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients developing symptomatic brain metastasis |  | 24 months after randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to develop neurological symptoms (confirmed or unconfirmed by imaging) |  | 24 months after randomisation | 
| Measurement of side effects (CTCAE3.0) |  | 24 months after randomisation | 
| Quality of Life | Measured by QLQ-C30 and EuroQol 5D | 24 months after randomisation |