Clinical trial NCT02555358: Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Clinical Study
Official title: Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Multicenter, Open, Randomized, Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Resectable advanced gastric cancer
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2015-09-21
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The pathological complete response rate
timeFrame: 24 weeks
Secondary outcomes:
measure: Overall survival(OS)
timeFrame: 3 years
measure: Progression-free survival(PFS)
timeFrame: 3 years
measure: Disease-free survival(DFS)
timeFrame: 3 years
measure: Adverse events
timeFrame: 3 years
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Fourth Affiliated Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: The 4th Hospital of Hebei Medical University
name: Qun Zhao, director
role: STUDY_CHAIR
References:
citation: 1. Zhao Q, Li Y, Tan BB, Tian Y, Jiao ZK, Zhao XF, Zhang ZD, Wang D, Yang PG. XELOX neoadjuvant chemotherapy for advanced gastric cancer resection rate and the impact on prognosis. Journal of Cancer 2013,35 (10) : 773-777 2. Zhao Q, Li Y, Wang GY, Jiao ZK, Zhao XF, Zhang ZD, Tan BB, Zhou CX, Sun WL laparoscopic abdominal control study of gastric cancer resection surgery clinical effect. Chinese General Practice, 2013,16 (1B): 210-215. 3.Zhao Q, Li Y, Tian Y, Chen YN, Tan BB, Zhao XF, Jiao ZK, Zhang ZD, Chang SL. Histological Complete Response after Neoadjuvant XELOX in Advanced Gastric Carcinoma. Hepatogastroenterology. 2013 Jan 24;60(126)