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Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy：A Multi-Center Randomized Phase ⅢTrial


Phase 3
18 Years
75 Years
Open (Enrolling by invite only)
Both
Brain Metastases

Thank you

Trial Information

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. 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) .

Outcome Time Frame:

2.5years

Safety Issue:

No

Principal Investigator

WU YI LONG, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese Society of Lung Cancer

Authority:

China: Food and Drug Administration

Study ID:

CSLC0801

NCT ID:

NCT00745797

Start Date:

April 2008

Completion Date:

October 2012

Related Keywords:

  • Brain Metastases
  • nonsmall cell lung cancer
  • brain metastasis
  • prophylactic cranial irradiation
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Brain Neoplasms

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