NCT01763385

Brief Summary

This project is aim to explore non-increased-intracranial-pressure symptomatic brain metastases of NSCLC, and if the OS of secondary brain radiotherapy after recurrence with Erlotinib is better than Erlotinib with concurrent brain radiotherapy. Treatment group are treated with Erlotinib until brain tumor progression, then gave brain radiotherapy, and continued to take Erlotinib till extracranial lesions progression. Control group are Erlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after radiotherapy until recurrence or termination for other reasons.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

3.5 years

First QC Date

January 4, 2013

Last Update Submit

December 22, 2014

Conditions

Non-small-cell Lung CancerBrain Metastases

Keywords

Erlotinibbrain radiotherapyNSCLCbrain metastases

Outcome Measures

Primary Outcomes (1)

  • overall survival

    3.5year

Study Arms (2)

Erlotinib & secondary brain radiotherapy

EXPERIMENTAL

Erlotinib until brain tumor progression, then given brain radiotherapy, and continued to take Erlotinib till extracranial lesions progression.

Drug: ErlotinibRadiation: secondary brain radiotherapy

Erlotinib & concurrent brain radiotherapy

OTHER

Erlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after radiotherapy until recurrence or termination for other reasons

Drug: ErlotinibRadiation: concurrent brain radiotherapy

Interventions

ErlotinibDRUG
Erlotinib & concurrent brain radiotherapyErlotinib & secondary brain radiotherapy
concurrent brain radiotherapyRADIATION
Erlotinib & concurrent brain radiotherapy
secondary brain radiotherapyRADIATION
Erlotinib & secondary brain radiotherapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over the age of 18 years old;
  • Tissue or cell pathological diagnosis of NSCLC;
  • Brain CT or MR validated BM;
  • Non-increased-intracranial-pressure symptomatic BM;
  • Haven't received TKI target treatment;
  • Haven't received brain radiotherapy;
  • Patients in initial treatment should be detected EGFR mutation;
  • Expected survival more than 6 months;
  • KPS no less than 70, or KPS less than 70 caused by paralysis due to recent brain metastases;
  • Liver and kidney function requirements: SGOT/SGPT≦2.5 times of the upper limit, Total bilirubin≦1.5 times of the upper limit, serum Creatinine≦1.5 times of the upper limit;
  • Routine blood test requirements: WBC≧3.0×109/L, NE≧1.8×109/L, PLT≧90×109/L，no requirement for Hb;
  • Blood glucose requirements: within the normal range, diabetic patients are receiving treatment and their glucose was being controlled in a steady state;
  • Female patients in childbearing age: HCG (-);
  • Patients signed an inform Consent.

You may not qualify if:

  • Those with Erlotinib drug allergies;
  • Those with mathematical understanding of the most simple life questions, such as "walking", those difficult for doctors to communicate;
  • Those without guardians or families;
  • Those with abnormal routine blood test, liver and kidney function, and blood glucose beyond the above boundaries and difficult to correcting for more than 2 weeks;
  • Those with any unstable medical status (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction (within one year before treatment initiation), and severe arrhythmia, liver, kidney or metabolic disease requiring drug therapy);
  • Those with any other disease, neurological or metabolic dysfunction, and physical examination or laboratory test results showed that the study drugs may increase the risk of treatment-related complications;
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungBrain Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Huanjun Yang

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huanjun Yang, Master

CONTACT

+86-21-64175590yanghj_1@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fudan University

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 8, 2013

Study Start

November 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

CN(1)