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

Phase 3

Terminated

• Conditions: Brain Metastases

• Registration Number: NCT00745797
• Lead Sponsor: Yi-Long Wu

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-09-02
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) .	2.5years

Secondary Outcome Measures

Name	Time	Method
1year survival,overall survival,incidence rate of radioactive brain injured	2 years

Trial Locations

Locations (1)

Lung Cancer Research Institute & Cancer Center of Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China