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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00745797

Acronym

PCI

Enrollment

Registered

2008-09-03

Start date

2008-04-30

Completion date

2012-08-31

Last updated

2017-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases

Keywords

nonsmall cell lung cancer, brain metastasis, prophylactic cranial irradiation

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.

Interventions

RADIATIONRadiotherapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
1year survival,overall survival,incidence rate of radioactive brain injured	2 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026