Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy (PCI)
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|