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

March 2, 2017 updated by: Yi-Long Wu

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

  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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Lung Cancer Research Institute & Cancer Center of Guangdong Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prophylactic WBRT
Take the whole brain radiotherapy radiotherapy
Radiation: Radiotherapy
blood transfusions, platelet transfusions, antibiotics, antipyretic analgesics and anesthetics
Other Names:
  • Radiotherapy,Dehydration drugs, elevated white blood drugs,
No Intervention: Observer Group
The first 14 days after randomization and patient follow-up after 1 month to complete the FACT-L questionnaire and the MMSE scale.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
1year survival,overall survival,incidence rate of radioactive brain injured
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yi-Long Wu

Investigators

  • Principal Investigator: WU YI LONG, MD, Chinese Society of Lung Cancer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

September 2, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSLC0801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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