A Comparison of Laparoscopic With Open Distal Gastrectomy in Advanced Gastric Cancer After Neoadjuvant Chemotherapy (REALIZATION)

Peking University

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Adjuvant Chemotherapy; Procedure: Laparoscopic gastrectomy; Procedure: Open gastrectomy; Drug: Neoadjuvant Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02404753

GISCA2015001/LAP

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and efficacy of laparoscopic distal D2 gastrectomy (LDG) compared with open surgery (ODG) for resectable gastric cancer, to determine whether LDG can be a test arm for a future Phase III trial to evaluate the non-inferiority of overall survival compared with ODG in patients who receive neoadjuvant chemotherapy.

Full description

The study is an open-label, controlled, randomized Phase II clinical trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital.

The primary endpoint is the 3-year progression-free survival (PFS) rate. The secondary endpoints are the overall survival, surgical morbidity and mortality.

Enrollment: 102 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven adenocarcinoma of the stomach.
• Clinical cT2N+M0,or cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and laparoscopy. The T and N stages are determined by the method of Habermann et al.
• The gastric tumors are located in the middle to lower third of the stomach, are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved.
• No bulky lymph node metastasis is detected by abdominal CT.
• No pleural effusion, no ascites exceeding the pelvis and no metastasis to the peritoneum, liver or other distant organs are confirmed by abdominal pelvic CT.
• No clinically apparent distant metastasis.
• Karnofsky performance status ≥70%.
• Sufficient oral intake.
• No previous treatment with chemotherapy or radiation therapy for any tumors.
• No previous surgery for the present disease.
• Sufficient organ function, as evaluated by laboratory tests 7 days or more after the date when the anticancer drugs were given. When patients are recovering from myelosuppression,the revised criteria are shown in parentheses.

White blood cell count≥3000/mm3 (2000/mm3) Platelet count≥10.0*104/mm3 (5.0*104/mm3) Aspartate aminotransferase≤100 IU/l Alanine aminotransferase≤100 IU/l Total bilirubin≤2.0 mg/dl Serum creatinine≤1.5 mg/dl

• No need for emergency surgery due to bleeding or perforation of the primary tumor.
• No mechanical obstruction.
• Written informed consent.

Exclusion criteria

• Past history of upper abdominal surgery.
• Past history of surgery for the gastrointestinal tract.
• Body mass index exceeding 30 kg/m2.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Laparoscopic gastrectomy

Experimental group

Description:

Laparoscopic distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.

Treatment:

Drug: Neoadjuvant Chemotherapy

Procedure: Laparoscopic gastrectomy

Drug: Adjuvant Chemotherapy

Open gastrectomy

Active Comparator group

Description:

Open distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.

Treatment:

Drug: Neoadjuvant Chemotherapy

Procedure: Open gastrectomy

Drug: Adjuvant Chemotherapy