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

Locally Advanced Gastric Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02048540
• Other study ID #: GC neoadjuvant bev CTC
• Secondary ID: BSC2013-dunan
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 25, 2014
• Last updated: April 23, 2014
• Start date: February 2009
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Locally Advanced Gastric Carcinoma
• Neoplastic Cells, Circulating
• Stomach Neoplasms

Intervention

Biological:
• 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.

Drug:
• 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.

Procedure:
• Gastrectomy

Locations

Country	Name	City	State
China	First Affiliated Hospital, Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	circulating tumor cell number change	to investigate the circulating tumor cell number change before and after neoadjuvant therapy and whether it's an effectiveness and survival predictor in LAGC	6 weeks	No
Primary	R0 resection rate		6-12 weeks after administration	No
Secondary	pCR rate		Day 1 after surgery	No
Secondary	OS		3 years after surgery	No
Secondary	DFS		3 years after surgery	No
Secondary	ORR		6 weeks after administration	No
Secondary	safety of peroperative treatment and surgery		from first administration to 28 days after last administration	Yes