Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy

Study Overview
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Brief Summary
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Patients with confirmed advanced NSCLC and any response to 3-6 cycles of chemotherapy, were randomized to receive PCI (30 Gy/10fr) or no PCI. The primary endpoint was the cumulative incidence of symptomatic brain metastases (BM) . The study was sized to detect a hazard ratio of 0.37 with 80% power and 2-sided 5% significance (60 events, 206 patients).

Detailed Description
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Prophylactic cranial irradiation (PCI) significantly reduces the risk of brain metastases (BM) and improves survival in patients with extensive disease small cell lung cancer after a response to chemotherapy . PCI has also demonstrated to reduce or delay the incidence of CNS failure in non small cell lung cancer patients after primary therapy. But its impact on overall and disease free survival is uncertain.

Official Title
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Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy：A Multi-center Randomized Phase ⅢTrial

Conditions
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Brain Metastases

Intervention / Treatment
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* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were required to have histologically or cytologically documented NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy No previous history of radiotherapy and surgery of brain Agree to radiotherapy age > 18 and <75 years ECOG performance status 1 or less Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB>=80g /DL) functions Have provided informed consent Exclusion Criteria: Seizure cannot be controled by the drugs Combined with other disease of the brain such as tumour or infarction Hypersensitivity to MR enhancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prophylactic WBRT<br>Take the whole brain radiotherapy radiotherapy | Radiation: Radiotherapy<br>* blood transfusions, platelet transfusions, antibiotics, antipyretic analgesics and anesthetics<br>* Other names: Radiotherapy,Dehydration drugs, elevated white blood drugs,;|
| No Intervention: Observer Group<br>The first 14 days after randomization and patient follow-up after 1 month to complete the FACT-L questionnaire and the MMSE scale. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) . |  | 2.5years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1year survival,overall survival,incidence rate of radioactive brain injured |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nonsmall cell lung cancer, brain metastasis, prophylactic cranial irradiation