Laparoscopic Versus Open Gastrectomy for Elderly Local Advanced Gastric Cancer Patients

NCT03564834 | Unknown Phase 2 DMC

• 1 other identifier: SF2018-4-2156
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric cancer is one of the most common malignant tumors worldwide. With the rapid aging of global population, the number of elderly patients with local advanced gastric cancer is increasing. Surgery is the essential treatment for local advanced gastric cancer. However, because of the degeneration of physiological organs, cell functions, compensatory ability, immunity, and physiological reserve ability, elderly patients often face great safety issues when having surgery. Therefore, how to treat the elderly patients with local advanced gastric cancer with safe and effective surgery is one of the important problems in the field of gastric cancer treatment. With the introduction of minimally invasive treatment concepts and techniques, the role of laparoscopic radical gastrectomy in the treatment of early gastric cancer, as well as the advantages of trauma control and postoperative accelerated rehabilitation have been confirmed, however, there is still a lack of sufficient high-level clinical evidence in the elderly patients with advanced gastric cancer. The current study therefore aims to evaluate the safety and efficacy of laparoscopic versus open gastrectomy for advanced gastric cancer in elderly patients, using a randomized parallel controlled study design. The investigators hypothesized that laparoscopic gastrectomy is superior to open gastrectomy in terms of perioperative safety for local advanced gastric cancer patients aged 70 and above.

Conditions

Advanced Gastric Cancer

Keywords

Elderly patients; Open gastrectomy; Laparoscopic gastrectomy

Outcome Measures

Primary Outcomes (1)

• Postoperative complication rate

  Surgery related complications include incision complications (infection, effusion, dehiscence, poor healing), peritoneal effusion or abscess formation, hemorrhage (inside abdominal cavity, inside digestive tract), ileus, anastomotic leakage, anastomotic stenosis, intestinal fistula, lymphatic leakage, pancreatic fistula, gastroparesis, pancreatitis, lung infection, pleural effusion, urinary tract infection, renal failure, liver failure, cardio-cerebrovascular events (both lower extremities thrombosis, pulmonary embolism, myocardial infarction, arrhythmia, cerebral infarction, etc.), and others. Complications will be reported and graded according to the Clavien-Dindo classification of surgical complications.

  within 30 days after surgery

Secondary Outcomes (5)

• Length of postoperative hospitalization stay

  within 30 days after surgery

• Postoperative life quality

  one-year after surgery

• Three-year overall survival rate

  Three-year after surgery

• Three-year disease-free survival rate

  Three-year after surgery

• Postoperative pain

  within 2 weeks after surgery

Study Arms (2)

Laparoscopic gastrectomy

EXPERIMENTAL

A standard laparoscopic gastrectomy with D2 lymphadenectomy will be performed by two experienced surgeons, according to the Japanese Gastric Cancer Treatment Guidelines 2014 (version 4) and the Japanese Classification of Gastric Carcinoma (3rd English edition).

Procedure: Laparoscopic gastrectomy

Open gastrectomy

ACTIVE COMPARATOR

A standard open gastrectomy with D2 lymphadenectomy will be performed by two experienced surgeons, according to the Japanese Gastric Cancer Treatment Guidelines 2014 (version 4) and the Japanese Classification of Gastric Carcinoma (3rd English edition).

Procedure: Open gastrectomy

Interventions

Laparoscopic gastrectomy PROCEDURE

Patients will receive laparoscopic gastrectomy within one week after randomization.

Laparoscopic gastrectomy

Open gastrectomy PROCEDURE

Patients will receive open gastrectomy within one week after randomization.

Open gastrectomy

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Ambulatory male or female aged 70 and above
• Karnofsky score≥70%
• Histologically proven gastric adenocarcinoma in biopsy (including Lauren classification) Proven clinical stage of cT2-4aNanyM0 by baseline ultrasound endoscope, enhanced CT/MRI examination, or diagnostic laparoscopy using Habermann Standards
• No past chemotherapy or radiotherapy before diagnosis
• Primary tumor located at stomach, achievable naked-eye complete resection (R0/1) via distal subtotal or total gastrectomy plus lymphadenectomy
• Haematology and biochemistry index meet the following: hemoglobin≥80g/L, absolute neutrophils count (ANC)≥1.5×109/L, platelet≥100×109/L, ALT、AST≤2.5 times the upper limit of normal value, ALP≤2.5 times the upper limit of normal value, serum total bilirubin\<1.5 times the upper limit of normal value, serum creatinine\<1 times the upper limit of normal value, serum albumin≥30g/L
• Heart and lung function can withstand surgery
• No severe concomitant disease that leads to survival\<3 years
• Willing and able to comply with study protocol Written agreement consent before enrolment and full aware of the right to quit the study at any time with no loss

You may not qualify if:

• Uncontrolled seizure, central nervous system diseases, or mental disorders;
• Past history of upper abdominal surgery (except for laparoscopic cholecystectomy)
• Past history of gastric surgery (including diagnosis procedure such as ESD and EMR)
• Other malignant diseases in 5 years (except for cured skin carcinoma and cervical carcinoma in situ)
• Clinical severe or active heart diseases, such as symptomatic coronary heart disease, NYHA grade II or above congestive heart failure, severe arrhythmia, or myocardial infarction in 6 months
• Cerebral hemorrhage or infarction in 6 months
• Organ transplant recipients under immunosuppressive therapy
• Severe uncontrolled repeated infection or other severe uncontrolled concomitant diseases
• Medium or severe renal damage (creatinine clearance rate≤50ml/min or serum creatinine\> upper limit of normal value)
• Other diseases requiring synchronous surgery
• Requiring emergent surgery due to oncologic emergent (e.g. bleeding, perforation, obstruction)
• FEV1\<50% of expected value Participated in other studies 4 weeks before the randomization.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (1)

• Li Z, Shan F, Ying X, Xue K, Ji J. Laparoscopic versus open gastrectomy for elderly local advanced gastric cancer patients: study protocol of a phase II randomized controlled trial. BMC Cancer. 2018 Nov 16;18(1):1118. doi: 10.1186/s12885-018-5041-y.

  PMID: 30445943 DERIVED

Study Officials

• Ziyu Li, MD

  Peking University Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Shan, MD

CONTACT

0086-10-88196606; shanfei@hsc.pku.edu.cn

Ziyu Li, MD

CONTACT

0086-10-88196605; ziyu_li@hsc.pku.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Department of Surgery

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: June 21, 2018
• Study Start: August 23, 2018
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2023
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 6 months after the completion of the trial
• Access Criteria: As request

Locations

CN (1)