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A Study of PC Sequential Pemetrexed Single Drug Maintenance Treatment for NSCLC and Related Predictive Biomarkers

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pemetrexed /carboplatin
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Progression free Survival

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

.≥65 years or PS 2

  • Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
  • Patients received no chemical therapy or only received targeted therapy,and there is evidence show the patent is PD

  • Presence of at least one index lesion measurable by CT scan or MRI

    • leucocyte ≥ 3.5×109/L
    • neutrophil ≥ 1.5×109/L
    • platelet ≥ 80×109/L
    • Hemoglobin ≥ 9g/L
    • ALT and AST ≤ 2.5×ULN ,Tbil≤ 1.5×ULN
  • BUN≤ 1.5×ULN
  • Signed written informed consent

Exclusion Criteria:

  • squamous carcinoma or small cell lung cancer
  • Patients were allergic to pemetrexed
  • Patients received chemotherapy before

  • Uncontrolled acute infection

    .Uncontrolled pleural effusion

  • Severe symptomatic heart disease
  • Severe infection or metabolic disfunction
  • Patients with other malignant tumor
  • Uncontrolled brain metastases
  • Patients have accepted other clinical trials

  • Female patients during their pregnant and lactation period, or patients without contraception

    • Mental disorientation of disorder
    • Glucocorticoids taboo

Sites / Locations

  • Cancer hospital Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pemetrexed

Arm Description

Outcomes

Primary Outcome Measures

PFS

Secondary Outcome Measures

Full Information

First Posted
May 20, 2013
Last Updated
July 4, 2013
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT01860508
Brief Title
A Study of PC Sequential Pemetrexed Single Drug Maintenance Treatment for NSCLC and Related Predictive Biomarkers
Official Title
Advanced Metastatic Non-small Cell Lung Cancer Patients Aged or PS Score 2 Points for First Line Application Pemetrexed/Carboplatin Chemotherapy Regimens Sequential Pemetrexed Single Drug Maintenance Treatment of Clinical Research and Related Predictive Biomarkers of Exploratory Research
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
PFS

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Progression free Survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pemetrexed
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
pemetrexed /carboplatin
Primary Outcome Measure Information:
Title
PFS
Time Frame
from the first cycle of treatment (day one) to two month after the last cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: .≥65 years or PS 2 Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer Patients received no chemical therapy or only received targeted therapy,and there is evidence show the patent is PD Presence of at least one index lesion measurable by CT scan or MRI leucocyte ≥ 3.5×109/L neutrophil ≥ 1.5×109/L platelet ≥ 80×109/L Hemoglobin ≥ 9g/L ALT and AST ≤ 2.5×ULN ,Tbil≤ 1.5×ULN BUN≤ 1.5×ULN Signed written informed consent Exclusion Criteria: squamous carcinoma or small cell lung cancer Patients were allergic to pemetrexed Patients received chemotherapy before Uncontrolled acute infection .Uncontrolled pleural effusion Severe symptomatic heart disease Severe infection or metabolic disfunction Patients with other malignant tumor Uncontrolled brain metastases Patients have accepted other clinical trials Female patients during their pregnant and lactation period, or patients without contraception Mental disorientation of disorder Glucocorticoids taboo
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia lei Wang, Master
Phone
02164175590
Ext
8907
Email
luwangjialei@hotmail.com
Facility Information:
Facility Name
Cancer hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia lei Wang, Master
Phone
02164175590
Ext
8907
Email
luwangjialei@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
29156802
Citation
Zhao X, Yu H, Zhao J, Wu X, Sun S, Luo Z, Wang H, Qiao J, Chang J, Wang J. Efficacy and safety of first-line pemetrexed plus carboplatin followed by single-agent pemetrexed maintenance in elderly Chinese patients with non-squamous non-small-cell lung cancer. Oncotarget. 2017 Sep 23;8(49):86384-86394. doi: 10.18632/oncotarget.21186. eCollection 2017 Oct 17.
Results Reference
derived

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A Study of PC Sequential Pemetrexed Single Drug Maintenance Treatment for NSCLC and Related Predictive Biomarkers

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