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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-TRC-11001194 |
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Date of registration:
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2011-02-21 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of pemetrexed/cisplatin in chemotherapy-naive Advanced Non Small Cell Lung Cancer (NSCLC)
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Scientific title:
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A Study of pemetrexed/cisplatin in chemotherapy-naive Advanced Non Small Cell Lung Cancer (NSCLC) |
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Date of first enrolment:
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2008-03-11 |
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Target sample size:
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experiment arm:108;control:106; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=8345 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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II (Phase II study)
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Countries of recruitment
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China
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Contacts
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Name:
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Yan SUN
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Address:
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17 Panjiayuan Nanli, Chaoyang District, Beijing, China
100210
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Telephone:
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+86 010 87788519 |
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Email:
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hejia63@yahoo.com |
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Affiliation:
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Cancer Hospital, Chinese Academy of Medical Sciences |
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Name:
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Jia He
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Address:
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800 Xiangyin Road, Shanghai, China
200433
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Telephone:
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+86 21 81871441 |
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Email:
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hejia63@yahoo.com |
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Affiliation:
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Second Military Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Eligible patients had histologically or cytologically confirmed, newly diagnosed unresectable stage IIIB/IV or recurrent (after surgery or radiotherapy) NSCLC;
2. patients with at least one unidimensionally measurable lesion according to RECIST (Response Evaluation Criteria in Solid Tumors), had an Eastern Cooperative Oncology Group (ECOG);
3. with performance status of 0 or 1, had a life expectancy of at least 12 weeks;
4. Aged older than 18 years;
5. had adequate hematologic, hepatic and renal function;
6. Patients with CNS metastases were accepted, but patients with sympotomatic disease were not;
7. No other malignant tumor;
8. Stopping chemotherapy for more than 4 weeks;
9. Signed informed consent.
Exclusion criteria: 1. pregnant/nursing women; history of other malignancies;
2. severe systemic disease that would potentially precluded chemotherapy treatment;
3. severe or uncontrolled conditions requiring medication or active infections;
4. and treatment with an investigational drug;
5. Patients were also excluded if they were unable to interrupt non-steroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or dexamethasone.
Age minimum:
18
Age maximum:
75
Gender:
Both
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Health Condition(s) or Problem(s) studied
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chemotherapy-naive NSCLC
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Intervention(s)
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experiment arm:pemetrexed at 500mg/m2 over 10 min plus cisplatin 75mg/m2 on day 1;control:gemcitabine 1,000 mg/m2 on days 1 and 8 plus cisplatin 75mg/m2 on day 1 ;
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Primary Outcome(s)
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time to progression;progression-free survival;
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Secondary Outcome(s)
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Clinical benefit rate;Time to treatment failure;Overall response rate;
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Source(s) of Monetary Support
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QILU Pharmceutical Co., Ltd.
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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