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)
Sponsor:
Information provided by (Responsible Party):
Yi-Long Wu, Chinese Society of Lung Cancer
ClinicalTrials.gov Identifier:
NCT00745797
First received: September 2, 2008
Last updated: January 27, 2014
Last verified: January 2014

September 2, 2008
January 27, 2014
April 2008
August 2012   (final data collection date for primary outcome measure)
The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) . [ Time Frame: 2.5years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00745797 on ClinicalTrials.gov Archive Site
1year survival,overall survival,incidence rate of radioactive brain injured [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy
Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy:A Multi-center Randomized Phase ⅢTrial
  1. 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.
  2. The primary endpoint was the cumulative incidence of symptomatic brain metastases (BM) .
  3. The study was sized to detect a hazard ratio of 0.37 with 80% power and 2-sided 5% significance (60 events, 206 patients).
  1. 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 .
  2. PCI has also demonstrated to reduce or delay the incidence of CNS failure in non small cell lung cancer patients after primary therapy.
  3. But its impact on overall and disease free survival is uncertain.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Brain Metastases
Radiation: Radiotherapy
blood transfusions, platelet transfusions, antibiotics, antipyretic analgesics and anesthetics
Other Name: Radiotherapy,Dehydration drugs, elevated white blood drugs,
  • Experimental: Prophylactic WBRT
    Take the whole brain radiotherapy radiotherapy
    Intervention: Radiation: Radiotherapy
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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
  2. No previous history of radiotherapy and surgery of brain
  3. Agree to radiotherapy
  4. age > 18 and <75 years
  5. ECOG performance status 1 or less
  6. Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB>=80g /DL) functions
  7. Have provided informed consent

Exclusion Criteria:

  1. Seizure cannot be controled by the drugs
  2. Combined with other disease of the brain such as tumour or infarction
  3. Hypersensitivity to MR enhancer
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00745797
CSLC0801
Yes
Yi-Long Wu, Chinese Society of Lung Cancer
Yi-Long Wu
Not Provided
Principal Investigator: WU YI LONG, MD Chinese Society of Lung Cancer
Chinese Society of Lung Cancer
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP