A Randomized, Single Center, Controlled Phase II Study to Compare Laparoscopic Versus Open Distal Gastrectomy in Locally Advanced Gastric Cancer After Neoadjuvant Chemotherapy
Overview
- Phase
- Phase 2
- Intervention
- Neoadjuvant Chemotherapy
- Conditions
- Gastric Cancer
- Sponsor
- Peking University
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- 3-year progression-free survival
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Ziyu Li, MD
Chief Physician,Associate Professor
Peking University
Eligibility Criteria
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.
Exclusion Criteria
- •Past history of upper abdominal surgery.
- •Past history of surgery for the gastrointestinal tract.
- •Body mass index exceeding 30 kg/m2.
Arms & Interventions
Laparoscopic gastrectomy
Laparoscopic distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.
Intervention: Neoadjuvant Chemotherapy
Laparoscopic gastrectomy
Laparoscopic distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.
Intervention: Laparoscopic gastrectomy
Laparoscopic gastrectomy
Laparoscopic distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.
Intervention: Adjuvant Chemotherapy
Open gastrectomy
Open distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.
Intervention: Neoadjuvant Chemotherapy
Open gastrectomy
Open distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.
Intervention: Open gastrectomy
Open gastrectomy
Open distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.
Intervention: Adjuvant Chemotherapy
Outcomes
Primary Outcomes
3-year progression-free survival
Time Frame: 36 months
In terms of locally advanced gastric cancer, to evaluate the disease free survival rate in laparoscopic subtotal gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open subtotal gastrectomy with D2 lymph node dissection
Secondary Outcomes
- Postoperative recovery index(2 weeks)
- Overall survival(36 months)
- Surgical morbidity(30 days)
- Postoperative quality of life(Up to 1 year post-operative)
- Surgical mortality(30 days)