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

Brain Metastases Clinical Trial

— PCI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00745797
• Other study ID #: CSLC0801
• Status: Terminated
• Phase: Phase 3
• First received: September 2, 2008
• Last updated: March 2, 2017
• Start date: April 2008
• Est. completion date: August 2012

Study information

• Verified date: March 2017
• Source: Chinese Society of Lung Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasm Metastasis

Intervention

Radiation:
• Radiotherapy
blood transfusions, platelet transfusions, antibiotics, antipyretic analgesics and anesthetics

Locations

Country	Name	City	State
China	Lung Cancer Research Institute & Cancer Center of Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Yi-Long Wu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) .		2.5years
Secondary	1year survival,overall survival,incidence rate of radioactive brain injured		2 years