Gastric Cancer
Conditions
Brief summary
Stage 1:First line therapy Sequential therapy of S1+Docetaxel followed by S1 is superior to concomitant S1+Docetaxel in the safety and clinical efficiency. Stage 2:Second line therapy To explore the feasibility of single drug(S1) maintenance treatment for advanced gastric cancer.
Interventions
DRUGS1+Docetaxel
Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks, Patients will receive S1+Docetaxel until progression
DRUGS1+Docetaxel followed by S1
Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks,for 4 cycles; S1 40-60mg, bid, days1-14, every 3 weeks Patients will receive S1+Docetaxel followed by S1 until progression
Sponsors
Hebei Tumor Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent form * Performance Status-Eastern Cooperative Oncology Group (ECOG) 0-1 * Histologically or cytologically confirmed gastric cancer * Advanced or recurrent, metastatic disease * At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors ) * Life expectancy of at least 3 months * Target target lesion has not received radiotherapy or non target lesion radiation at least 4 weeks * Haematopoietic and Hepatic status: Absolute neutrophil count \>1.5x109/L,Platelet count \> 100 x 109/L,Hemoglobin at least 9 g/dl,Bilirubin ≤ 1.5 x upper limit of normal (ULN),AST and ALT ≤ 2.5 times ULN(no liver metastasis), ≤5 times ULN(with liver metastasis) * Cardiovascular: Baseline LVEF 50% measured by echocardiography
Exclusion criteria
* Symptomatic brain metastasis * Active or uncontrolled infection * Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2; peripheral neuropathy of grade 2 or greater Symptomatic brain metastasis * Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen * History of other malignancy * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival(PFS) | 1 years |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR) | 1 year |
| Disease control rate(DCR) | 1 year |
| Overall survival(OS) | 3 years |
Countries
China
Outcome results
None listed