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NCT Number: NCT02048540

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

First Affiliated Hospital, Chinese PLA General Hospital

Beijing, Beijing Municipality, 100048, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

gastrectomy

Procedure

Primary outcomes

  1. R0 resection rate

    Time frame: 6-12 weeks after administration

Secondary outcomes

  1. pCR rate

    Time frame: Day 1 after surgery

  2. OS

    Time frame: 3 years after surgery

  3. DFS

    Time frame: 3 years after surgery

  4. ORR

    Time frame: 6 weeks after administration

  5. safety of peroperative treatment and surgery

    Time frame: from first administration to 28 days after last administration

Other outcomes

  1. circulating tumor cell number change

    Time frame: 6 weeks

    to investigate the circulating tumor cell number change before and after neoadjuvant therapy and whether it's an effectiveness and survival predictor in LAGC

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

Phase 2 Study of Neoadjuvant Bevacizumab Plus DOF Versus DOF in Local Advanced Gastric Carcinoma and Its Association With Circulating Tumor Cell

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 29, 2014
Registry last updated
Apr 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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