Gastric Cancer
Conditions
Keywords
Resectable advanced gastric cancer
Brief summary
The purpose of this study is to assess the relationship of pCR rate and efficacy by comparing the two drugs and three drugs as neoadjuvant chemotherapy in advanced gastric cancer patients.
Detailed description
Eligible patients will be randomly assigned by a randomisation system in a 1:1:1 ratio to three group. The group A wil receive four cycles of DOX (docetaxel 60mg/m2 on day 1,oxaliplatin 130mg/m2 on day 1 and capecitabine 1,000 mg/m2 per day on days 1 to 14, repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy.The group B wil receive four cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox as adjuvant therapy.The group C wil receive eight cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy.
Interventions
DRUGdocetaxel,0xaliplatin,capecitabine
docetaxel 60mg/m2， ivgtt，2h，d1;capecitabine 1000mg/m2 po bid d1-14; oxaliplatin 130mg/m2， ivgtt，2h，d1;q21d
DRUGoxaliplatin,capecitabine
oxaliplatin 130mg/m2， ivgtt，2h，d1;capecitabine 1000mg/m2 po bid d1-14;q21d
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Qun Zhao
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically proven in operable advanced gastric adenocarcinoma; 2. Subjects who were identified as potentially resectable cases by a multidisciplinary consultation; 3. KPS\> 80; ECOG score: 0-1; 4. Expected survival\> 6 months; 5. Age 20 -60; 6. Major organ function has to meet the following criteria: Neutrophil count ≥1.5 × 109 / L, platelet count ≥100 × 109 / L, Hemoglobin ≥90g / L, liver function \<1.5 times the upper limit of normal, serum bilirubin ≤1.0 × UNL, serum creatinine \<1.5 × UNL, PT-INR / PTT \<1.7 times the upper limit of normal; 7. Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;
Exclusion criteria
1. Associated with serious diseases in liver ,kidney, cardiovascular system and other vital organs; 2. History of hypersensitivity to docetaxel, capecitabine, oxaliplatin or the ingredients of this product; 3. Receiving any form of chemotherapy or other study medication; 4. Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method; 5. Associated with inability to swallow, haemorrhagic peptic ulcer, mechanical or paralytic ileus, gastrointestinal active bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pathological complete response rate | 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival(OS) | 3 years | — |
| Progression-free survival(PFS) | 3 years | — |
| Disease-free survival(DFS) | 3 years | — |
| Adverse events | 3 years | Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0. The number of Participants with adverse events will be recorded at each treatment visit. |
Countries
China
Outcome results
None listed