Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy
This study has been terminated.
(this trial enroll extremely slow and No funding support)
Information provided by (Responsible Party):
Yi-Long Wu, Chinese Society of Lung Cancer
First received: September 2, 2008
Last updated: January 27, 2014
Last verified: January 2014
- 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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
Resource links provided by NLM:
Further study details as provided by Chinese Society of Lung Cancer:
Primary Outcome Measures:
- The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) . [ Time Frame: 2.5years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 1year survival,overall survival,incidence rate of radioactive brain injured [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2008|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
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.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00745797
|Lung Cancer Research Institute & Cancer Center of Guangdong Provincial People's Hospital|
|Guangzhou, Guangdong, China, 510080|
Sponsors and Collaborators
|Principal Investigator:||WU YI LONG, MD||Chinese Society of Lung Cancer|