A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer
This trial is active, not recruiting.
|Treatments||raltitrexed plus docetaxel, docetaxel|
|Sponsor||Hebei Tumor Hospital|
|Start date||April 2013|
|End date||December 2016|
|Trial size||100 participants|
|Trial identifier||NCT01836120, HBTH103|
A study of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with Gastric Cancer.The purpose of this study is to compare the activity of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with gastric carcinoma by estimating progression free survival (PFS) in each treatment arm.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Progression-free survival (PFS)
time frame: 1 years
Objective Response Rate (ORR)
time frame: 1 year
Overall Survival (OS)
time frame: 1 year
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria: 1. Signed informed consent form 2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2; 3. Histologically or cytologically confirmed gastric cancer; 4. The first-line chemotherapy failure (required containing 5-fluorouracil) 5. At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors ) 6. Life expectancy of at least 3 months; Exclusion Criteria: 1. Received any prior treatment including Raltitrexed; 2. Active or uncontrolled infection; 3. Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial; 4. Pregnant or lactating women.
|Official title||A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer|
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