Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer (COACT_1001)

National Cancer Center (NCC)

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer

Treatments: Procedure: open distal gastrectomy; Procedure: laparoscopy assisted distal gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01088204

NCCCTS-09-448

Details and patient eligibility

About

The purpose of this study is to evaluate the oncological feasibility of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for advanced gastric cancer.

Full description

To test oncological feasibility, compliance of nodal dissection was selected as a primary end point. When there are more than two missing nodal station(no lymph nodes in dissected area), it is defined as a non-compliant nodal dissection. Other secondary outcomes will be supplementary to evaluate feasibility of D2 dissection.

Enrollment: 204 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically proven primary gastric adenocarcinoma

• T2 or T3 or T4a, N0 or N1 or N2 or N3a (AJCC 7th), which is assessed by computed tomography (CT) scan - mid 1/3 or low 1/3 location

• No evidence of other distant metastasis

• not stump carcinoma,(vi) aged 20-80 year old

• performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale

• no prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection

• adequate organ functions defined as indicated below:

  • WBC 3000/mm3, WBC 12 000/mm3
  • Hb 8.0 g/dl without any transfusion 2 weeks before enrollment
  • Plt 100 000/mm3
  • AST 100 IU/l
  • ALT 100 IU/l
  • T.Bil 2.0 mg/dl
  • written informed consent

Exclusion criteria

• active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer)
• pregnant or breast-feeding women
• severe mental disorder
• systemic administration of corticosteroids
• unstable angina or myocardial infarction within 6 months of the trial
• unstable hypertension
• severe respiratory disease requiring continuous oxygen therapy
• previous upper abdominal surgery except laparoscopic cholecystectomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

open distal gastrectomy

Active Comparator group

Description:

open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer

Treatment:

Procedure: open distal gastrectomy

laparoscopy assisted distal gastrectomy

Experimental group

Description:

laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer

Treatment:

Procedure: laparoscopy assisted distal gastrectomy