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

NCT00745797 | Terminated Phase 3 DMC

• 1 other identifier: CSLC0801
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.The primary endpoint was the cumulative incidence of symptomatic brain metastases (BM) .
3. 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).

Conditions

Brain Metastases

Keywords

nonsmall cell lung cancer; brain metastasis; prophylactic cranial irradiation

Outcome Measures

Primary Outcomes (1)

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

  2.5years

Secondary Outcomes (1)

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

  2 years

Study Arms (2)

Prophylactic WBRT

EXPERIMENTAL

Take the whole brain radiotherapy radiotherapy

Radiation: Radiotherapy

Observer Group

NO INTERVENTION

The first 14 days after randomization and patient follow-up after 1 month to complete the FACT-L questionnaire and the MMSE scale.

Interventions

Radiotherapy RADIATION

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

Also known as: Radiotherapy,Dehydration drugs, elevated white blood drugs,

Prophylactic WBRT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• No previous history of radiotherapy and surgery of brain
• Agree to radiotherapy
• age \> 18 and \<75 years
• ECOG performance status 1 or less
• Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB\>=80g /DL) functions
• Have provided informed consent

You may not qualify if:

• Seizure cannot be controled by the drugs
• Combined with other disease of the brain such as tumour or infarction
• Hypersensitivity to MR enhancer

Sponsors & Collaborators

• Yi-Long Wu: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Brain Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• WU YI LONG, MD

  Chinese Society of Lung Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, director

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 3, 2008
• Study Start: April 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 6, 2017

Record last verified: 2017-03

Locations

CN (1)