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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Chinese Society of Lung Cancer
ClinicalTrials.gov Identifier:
NCT00745797
First received: September 2, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted

September 2, 2008
September 2, 2008
April 2008
March 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
No Changes Posted
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: Prophylactic cranial irradiation
30GY/15fraction
Other Name: linear accelerator
  • No Intervention: A
    No PCI
  • Experimental: B
    PCI of 30GY/15f
    Intervention: Radiation: Prophylactic cranial irradiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
206
October 2012
March 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
Yilong Wu, Chinese Society of Lung Cancer
Chinese Society of Lung Cancer
Not Provided
Principal Investigator: WU YI LONG, MD Chinese Society of Lung Cancer
Chinese Society of Lung Cancer
September 2008

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