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

Gastric Cancer Clinical Trial

Official title:

Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Multicenter, Open, Randomized, Controlled Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555358
• Other study ID #: Alien Craft 0004
• Status: Completed
• Phase: Phase 2
• Start date: November 2014
• Est. completion date: June 2022

Study information

• Verified date: October 2023
• Source: Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• docetaxel,0xaliplatin,capecitabine
docetaxel 60mg/m2, ivgtt,2h,d1;capecitabine 1000mg/m2 po bid d1-14; oxaliplatin 130mg/m2, ivgtt,2h,d1;q21d
• oxaliplatin,capecitabine
oxaliplatin 130mg/m2, ivgtt,2h,d1;capecitabine 1000mg/m2 po bid d1-14;q21d

Locations

Country	Name	City	State
China	Fourth Affiliated Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Qun Zhao	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pathological complete response rate		24 weeks
Secondary	Overall survival(OS)		3 years
Secondary	Progression-free survival(PFS)		3 years
Secondary	Disease-free survival(DFS)		3 years
Secondary	Adverse events	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.	3 years