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

Qun Zhao

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: oxaliplatin,capecitabine; Drug: docetaxel,0xaliplatin,capecitabine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02555358

Alien Craft 0004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

A（DOX）

Experimental group

Description:

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

Treatment:

Drug: docetaxel,0xaliplatin,capecitabine

B（Xelox）

Active Comparator group

Description:

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

Treatment:

Drug: oxaliplatin,capecitabine

C（Xelox）

Active Comparator group

Description:

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.

Treatment:

Drug: oxaliplatin,capecitabine