Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Clinical Study

Phase 2

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: docetaxel,0xaliplatin,capecitabine; Drug: oxaliplatin,capecitabine

• Registration Number: NCT02555358
• Lead Sponsor: Qun Zhao

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-21
• Primary Completion: 2021-12
• Study Completion: 2022-06
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
A（DOX）	docetaxel,0xaliplatin,capecitabine	Interventions：This arm 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
B（Xelox）	oxaliplatin,capecitabine	Interventions：This arm 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
C（Xelox）	oxaliplatin,capecitabine	Interventions：This arm 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.

Primary Outcome Measures

Name	Time	Method
The pathological complete response rate	24 weeks

Secondary Outcome Measures

Name	Time	Method
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.
Overall survival(OS)	3 years

Trial Locations

Locations (1)

Fourth Affiliated Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China