Prophylactic Cranial Irradiation (PCI) Versus no PCI in N... | NCT00745797

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

NCT00745797

Sponsor

Yi-Long Wu

Status

Terminated

Last Update Posted

Mar 6, 2017Actual

Enrollment

5Actual

Phase

Phase 3

Conditions

Brain Metastases

Interventions

Radiotherapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

this trial enroll extremely slow and No funding support

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Sep 2, 2008

First Submission Date that Met QC Criteria

Sep 2, 2008

First Posted Date

Sep 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2017

Last Update Posted Date

Mar 6, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Radiotherapy	Radiation	blood transfusions, platelet transfusions, antibiotics, antipyretic analgesics and anesthetics	Prophylactic WBRT

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
WU YI LONG, MD	Chinese Society of Lung Cancer	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lung Cancer Research Institute & Cancer Center of Guangdong Provincial People's Hospital		Guangzhou	Guangdong	510080	China

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided