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Trial Title:
A Study of PC Sequential Pemetrexed Single Drug Maintenance Treatment for NSCLC and Related Predictive Biomarkers
NCT ID:
NCT01860508
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pemetrexed
Conditions: Keywords:
Progression free Survival
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
pemetrexed /carboplatin
Arm group label:
pemetrexed
Summary:
PFS
Criteria for 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
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer hospital Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Jia lei Wang, Master
Phone:
02164175590
Phone ext:
8907
Email:
luwangjialei@hotmail.com
Start date:
February 2013
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01860508
