Clinical trial NCT02048540: Neoadjuvant Bev Plus DOF vs DOF in LAGC and Its Association With Circulating Tumor Cell
Official title: Phase 2 Study of Neoadjuvant Bevacizumab Plus DOF Versus DOF in Local Advanced Gastric Carcinoma and Its Association With Circulating Tumor Cell
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Locally Advanced Gastric Carcinoma
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: R0 resection rate
timeFrame: 6-12 weeks after administration
Secondary outcomes:
measure: pCR rate
timeFrame: Day 1 after surgery
measure: OS
timeFrame: 3 years after surgery
measure: DFS
timeFrame: 3 years after surgery
measure: ORR
timeFrame: 6 weeks after administration
measure: safety of peroperative treatment and surgery
timeFrame: from first administration to 28 days after last administration
Other outcomes:
measure: circulating tumor cell number change
timeFrame: 6 weeks
Locations:
city: Beijing
country: China
facility: First Affiliated Hospital, Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: First Affiliated Hospital, Chinese PLA General Hospital
name: Nan Du, Phd
role: PRINCIPAL_INVESTIGATOR
References: