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

Primary Purpose

Brain Metastases

Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
Yi-Long Wu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Brain Metastases focused on measuring nonsmall cell lung cancer, brain metastasis, prophylactic cranial irradiation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prophylactic WBRT

Observer Group

Arm Description

Take the whole brain radiotherapy radiotherapy

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 2, 2008
Last Updated
March 2, 2017
Sponsor
Yi-Long Wu
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1. Study Identification

Unique Protocol Identification Number
NCT00745797
Brief Title
Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
this trial enroll extremely slow and No funding support
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yi-Long Wu

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. The primary endpoint was the cumulative incidence of symptomatic brain metastases (BM) . 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
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 . PCI has also demonstrated to reduce or delay the incidence of CNS failure in non small cell lung cancer patients after primary therapy. But its impact on overall and disease free survival is uncertain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
nonsmall cell lung cancer, brain metastasis, prophylactic cranial irradiation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prophylactic WBRT
Arm Type
Experimental
Arm Description
Take the whole brain radiotherapy radiotherapy
Arm Title
Observer Group
Arm Type
No Intervention
Arm Description
The first 14 days after randomization and patient follow-up after 1 month to complete the FACT-L questionnaire and the MMSE scale.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
Radiotherapy,Dehydration drugs, elevated white blood drugs,
Intervention Description
blood transfusions, platelet transfusions, antibiotics, antipyretic analgesics and anesthetics
Primary Outcome Measure Information:
Title
The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) .
Time Frame
2.5years
Secondary Outcome Measure Information:
Title
1year survival,overall survival,incidence rate of radioactive brain injured
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Seizure cannot be controled by the drugs Combined with other disease of the brain such as tumour or infarction Hypersensitivity to MR enhancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WU YI LONG, MD
Organizational Affiliation
Chinese Society of Lung Cancer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lung Cancer Research Institute & Cancer Center of Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

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

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