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The purpose of this study is to investigate the PFS, ORR, OS and overall toxicity value(OTV)on advanced adenocarcinoma treated with nedaplatin or cisplatin combined with pemetrexed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nedaplatin and Pemetrexed | Experimental | nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 (Every three weeks for a treatment cycle) |
|
| Cisplatin and Pemetrexed | Active Comparator | cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 (Every three weeks for a treatment cycle) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin and pemetrexed | Drug | cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 (Every three weeks for a treatment cycle) |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression free-survival(PFS) | Progression-free survival is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first | 12months |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | ORR is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR). | 12months |
| overall survival(OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| li-kun chen, Doctor | Contact | 13798019964 | chenlk@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| li-kun Chen, Doctor | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University of cancer center | Recruiting | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14691125 | Result | Pfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker S Jr, Olak J, Stover D, Strawn JR, Turrisi AT, Somerfield MR; American Society of Clinical Oncology. American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol. 2004 Jan 15;22(2):330-53. doi: 10.1200/JCO.2004.09.053. Epub 2003 Dec 22. No abstract available. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| nedaplatin+pemetrexed | Drug | nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 (Every three weeks for a treatment cycle) |
|
OS is defined as the time from the starting date of study drug to the date of death due to any cause
| 24 months |
| overall toxicity value | toxicity graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0 | 12 months |
| Progression-Free Survival (PFS) rate at 18 weeks | the proportion (%) of patients without disease progression at 18 weeks | 20 weeks |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006147 |
| Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |