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

Gastric Cancer Clinical Trial

— REALIZATION  

Official title:

A Randomized, Single Center, Controlled Phase II Study to Compare Laparoscopic Versus Open Distal Gastrectomy in Locally Advanced Gastric Cancer After Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02404753
• Other study ID #: GISCA2015001/LAP
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 2015
• Est. completion date: November 25, 2022

Study information

• Verified date: September 2018
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: November 25, 2022
• Est. primary completion date: November 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Neoadjuvant Chemotherapy
XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine 1000mg/m2,po.,Bid,d1-14; Repeat every 21 days for 3 courses.

Procedure:
• Laparoscopic gastrectomy
Laparoscopic distal gastrectomy with D2 lymph node dissection
• Open gastrectomy
Open distal gastrectomy with D2 lymph node dissection

Drug:
• Adjuvant Chemotherapy
XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine 1000mg/m2,po.,Bid,d1-14; Repeat every 21 days for 5 courses.

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

References & Publications (2)

Li Z, Shan F, Wang Y, Li S, Jia Y, Zhang L, Yin D, Ji J. Laparoscopic versus open distal gastrectomy for locally advanced gastric cancer after neoadjuvant chemotherapy: safety and short-term oncologic results. Surg Endosc. 2016 Oct;30(10):4265-71. doi: 10.1007/s00464-015-4739-z. Epub 2016 Jun 10. — View Citation

Li Z, Shan F, Ying X, Zhang L, Ren H, Li S, Jia Y, Miao R, Xue K, Li Z, Wang Y, Yan C, Zhang Y, Pang F, Ji J. Laparoscopic or open distal gastrectomy after neoadjuvant chemotherapy for advanced gastric cancer: study protocol for a randomised phase II trial. BMJ Open. 2018 Aug 10;8(8):e021633. doi: 10.1136/bmjopen-2018-021633. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year progression-free survival	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	36 months
Secondary	Overall survival	In terms of locally advanced gastric cancer, to evaluate the overall 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	36 months
Secondary	Surgical morbidity	Surgical morbidity is defined as the events which occurs with-in postoperative 30 days, extension of hospitalization and re-hospitalization. It is necessary to evaluate the complication and if it occurs during the hospitalization, it is required to record complication name, date of on-set (postoperatively), grade on Clavien-Dindo Classification and treatment for complication.	30 days
Secondary	Surgical mortality	It is defined as the death within postoperative 30 days regardless of postoperative reason. If the patient is transferred to other medication institutes with impossible condition for recovery before death, it is regarded as death.	30 days
Secondary	Postoperative recovery index	Postoperatively, the investigator evaluates the patient's recovery condition once a day. Evaluation items for patient's recovery condition: the pain score, the leaving bed time, postoperative gastrointestinal function recovery time and hospital stay.	2 weeks
Secondary	Postoperative quality of life	In pre-therapy <7 days, pre-operative <7 days, and post-operative at 12 months after surgery, both the European Organisation for Research and Treatment of Cancer (EORTC) C30 and STO22 are analyzed with quality of life by following methods. In case of EORTC-C30, the analysis is undergone by classifying into 5 functional scales (physical, role, emotional, cognitive, and social functioning), 3 symptom scales (fatigue, pain and nausea, and vomiting), 1 global health status and 6 single items.	Up to 1 year post-operative