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

Phase 3TerminatedNCT00745797

Yi-Long Wu5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Brain Metastases

Interventions

RadiotherapyRADIATION

blood transfusions, platelet transfusions, antibiotics, antipyretic analgesics and anesthetics

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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

Time frame: 2.5years

Secondary Outcomes

1year survival,overall survival,incidence rate of radioactive brain injured

Time frame: 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.