Neoadjuvant Bev Plus DOF vs DOF in LAGC and Its Association With Circulating Tumor Cell

NCT ID: NCT02048540

Last Updated: 2014-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2013-12-31

Brief Summary

Background Local advanced gastric carcinoma (LAGC) is suggested to be potentially cured by R0 resection, and neoadjuvant chemotherapy can increase the R0 resection rate but not enough. Bevacizumab (Bev), an anti-tumor angiogenesis monoclonal antibody, combined with chemotherapy has been shown effective in advanced GC. In addition, CTC has been suggested as an indicator of the anti-tumor drugs' efficacy. Therefore, in this study, the investigators plan to evaluate the efficacy and safety of neoadjuvant Bev plus docetaxel/oxaliplatin/5-FU/CF (DOF) versus DOF in mainly gastric antrum LAGC, and to investigate whether CTC is an effectiveness indicator.

Methods 86 patients diagnosed as IIIb-IIIc GC have been enrolled and randomly assigned (1:1) to receive neoadjuvant Bev (5 mg/kg, d1) plus DOF (docetaxel, 75 mg/m2, iv, d1; oxaliplatin, 85 mg/m2, iv, d1; 5-FU, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; CF, 200 mg/m2, d1 and d2) or DOF each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles. The primary endpoint is R0 resection rate. CTC was detected every 8 weeks. All patients signed the informed consent.

Conditions

Locally Advanced Gastric Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bevacizumab plus DOF

patients receive bev +DOF pre and post surgery up to total 6 cycles

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: BIOLOGICAL

Bev (5 mg/kg, d1) every 3 weeks, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles.

docetaxel oxaliplatin 5-FU CF

Intervention Type: DRUG

docetaxel, 75 mg/m2, iv, d1; oxaliplatin, 85 mg/m2, iv, d1; 5-FU, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; CF, 200 mg/m2, d1 and d2 each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles.

Gastrectomy

Intervention Type: PROCEDURE

DOF

patients receive DOF pre and post surgery up to total 6 cycles

Group Type: ACTIVE_COMPARATOR

docetaxel oxaliplatin 5-FU CF

Intervention Type: DRUG

docetaxel, 75 mg/m2, iv, d1; oxaliplatin, 85 mg/m2, iv, d1; 5-FU, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; CF, 200 mg/m2, d1 and d2 each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles.

Gastrectomy

Intervention Type: PROCEDURE

Interventions

Bevacizumab

Bev (5 mg/kg, d1) every 3 weeks, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles.

Intervention Type: BIOLOGICAL

docetaxel oxaliplatin 5-FU CF

docetaxel, 75 mg/m2, iv, d1; oxaliplatin, 85 mg/m2, iv, d1; 5-FU, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; CF, 200 mg/m2, d1 and d2 each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles.

Intervention Type: DRUG

Gastrectomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed locally advanced adenocarcinoma of the stomach.
• Age of 18 to 70, Karnofsky score higher than 80.
• T3-4，N1-3，M0 (AJCC 7th), potentially resectable.
• No severe functional damage of major organ, normal blood cell, normal liver and kidney function.

Exclusion Criteria

• Clinical findings of distant metastasis or Peritoneal carcinomatosis
• Prior systemic (chemo- or targeted) treatment. Prior radiotherapy to the upper abdomen
• Previous malignancy within 5 years, with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
• Upper gastrointestinal bleeding
• Any contraindication to treatment with docetaxel, 5-fu or oxaliplatin

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

DuNan

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nan Du, Phd

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Chinese PLA General Hospital

Locations

First Affiliated Hospital, Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

BSC2013-dunan

Identifier Type: OTHER

Identifier Source: secondary_id

GC neoadjuvant bev CTC

Identifier Type: -

Identifier Source: org_study_id