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

NCT02048540 | Completed Phase 1

• 2 other identifiers: GC neoadjuvant bev CTCBSC2013-dunan
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  6-12 weeks after administration

Secondary Outcomes (5)

• pCR rate

  Day 1 after surgery

• OS

  3 years after surgery

• DFS

  3 years after surgery

• ORR

  6 weeks after administration

• safety of peroperative treatment and surgery

  from first administration to 28 days after last administration

Other Outcomes (1)

• circulating tumor cell number change

  6 weeks

Study Arms (2)

bevacizumab plus DOF

EXPERIMENTAL

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

Biological: Bevacizumab; Drug: docetaxel oxaliplatin 5-FU CF; Procedure: Gastrectomy

DOF

ACTIVE COMPARATOR

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

Drug: docetaxel oxaliplatin 5-FU CF; Procedure: Gastrectomy

Interventions

Bevacizumab 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.

bevacizumab plus DOF

docetaxel oxaliplatin 5-FU CF 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.

DOF; bevacizumab plus DOF

Gastrectomy PROCEDURE

DOF; bevacizumab plus DOF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

First Affiliated Hospital, Chinese PLA General Hospital

Beijing, Beijing Municipality, 100048, China

Location

MeSH Terms

Interventions

Bevacizumab; Gastrectomy

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Nan Du, Phd

  First Affiliated Hospital, Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 25, 2014
• First Posted: January 29, 2014
• Study Start: February 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 25, 2014

Record last verified: 2014-04

Locations

CN (1)