- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01769066
Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum for Advanced NSCLC
February 22, 2016 updated by: Chang Jian Hua, Fudan University
Random Open Exploratory Clinical Research of Sequential Gefitinib With Pemetrexed/Platinum Compare With Pemetrexed/Platinum Treatment for Advanced Non-small Cell Lung Cancer Exploratory Clinical Research
The aim of this study is to explore the Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients will be randomized to 2 groups
Study Type
Interventional
Enrollment (Actual)
117
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Cancer hospital Fudan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18~70 years
- Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer
- Presence of at least one index lesion measurable by CT scan or MRI
- Ecog0-1
- Expected life time longer than 12 weeks
Normal laboratory values:
- leucocyte ≥ 4×109/L
- neutrophil ≥ 1.5×109/L
- platelet ≥ 100×109/L
- Hemoglobin ≥ 10g/L
- ALT and
- AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis)
- Signed written informed consent
Exclusion Criteria:
- Patients have used drugs according to protocol
- Patients were allergic to pemetrexed or cisplatin
- Patients received radiotherapy or other biological treatment 4 weeks before the trial
- Uncontrolled hydrothorax or hydropericardium
- neuropathy toxicity ≥ CTC 3
- Severe symptomatic heart disease
- Active upper gastrointestinal ulcer or digestive disfunction
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sequential Gefitinib With Pemetrexed/Platinum
Pemetrexed IV 500 mg/m2 ,DAY2 DDP IV 75mg/m2 ,DAY1 OR CAP IV AUC 5,DAY1 Gefitinib PO. 250mg DAY3-16
|
|
Active Comparator: Pemetrexed/Platinum
Pemetrexed IV 500 mg/m2 ,DAY2 DDP IV 75mg/m2 ,DAY1 OR CAP IV AUC 5,DAY1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
12 weeks of non-progression rate
Time Frame: from the first cycle of treatment (day one) to two month after the last cycle
|
from the first cycle of treatment (day one) to two month after the last cycle
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PFS
Time Frame: from the first cycle of treatment (day one) to two month after the last cycle
|
from the first cycle of treatment (day one) to two month after the last cycle
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chang jian hua, MD,PhD, Cancer hospital Fudan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
January 10, 2013
First Submitted That Met QC Criteria
January 14, 2013
First Posted (Estimate)
January 16, 2013
Study Record Updates
Last Update Posted (Estimate)
February 23, 2016
Last Update Submitted That Met QC Criteria
February 22, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gefitinib-2009-cjh
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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