Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy (PCI)
|ClinicalTrials.gov Identifier: NCT00745797|
Recruitment Status : Terminated (this trial enroll extremely slow and No funding support)
First Posted : September 3, 2008
Last Update Posted : March 6, 2017
- 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).
|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases||Radiation: Radiotherapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy：A Multi-center Randomized Phase ⅢTrial|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Experimental: Prophylactic WBRT
Take the whole brain radiotherapy radiotherapy
blood transfusions, platelet transfusions, antibiotics, antipyretic analgesics and anesthetics
Other Name: Radiotherapy,Dehydration drugs, elevated white blood drugs,
No Intervention: Observer Group
The first 14 days after randomization and patient follow-up after 1 month to complete the FACT-L questionnaire and the MMSE scale.
- The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) . [ Time Frame: 2.5years ]
- 1year survival,overall survival,incidence rate of radioactive brain injured [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745797
|Lung Cancer Research Institute & Cancer Center of Guangdong Provincial People's Hospital|
|Guangzhou, Guangdong, China, 510080|
|Principal Investigator:||WU YI LONG, MD||Chinese Society of Lung Cancer|