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

Last updated: March 2, 2017
Sponsor: Yi-Long Wu
Overall Status: Terminated

Phase

3

Condition

Brain Metastases

Neoplasm Metastasis

Treatment

N/A

Clinical Study ID

NCT00745797
CSLC0801
  • Ages 18-75
  • All Genders

Study Summary

  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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients were required to have histologically or cytologically documented NSCLC and nobrain metastasis documented by magnetic resonance imaging (MRI)within 21 days afterconfirmed 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 andplatelet count 90 x 109/L,HB>=80g /DL) functions

  7. Have provided informed consent

Exclusion

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

Study Design

Total Participants: 5
Study Start date:
April 01, 2008
Estimated Completion Date:
August 31, 2012

Study Description

  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.

Connect with a study center

  • Lung Cancer Research Institute & Cancer Center of Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.