Laparoscopic Versus Open Gastrectomy for Elderly Local Advanced Gastric Cancer Patients

September 26, 2018 updated by: Ziyu Li, MD, Peking University

Laparoscopic Versus Open Gastrectomy for Elderly Local Advanced Gastric Cancer Patients: a Phase II Randomized Parallel Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Gastric cancer is one of the most common cancer and cause of cancer death worldwide. With the rapid aging of global population, the number of elderly patients with local advanced gastric cancer has been continuously increasing. Surgery is the essential treatment for local advanced gastric cancer. However, elderly patients are at high risk of postoperative complications due to reduced functional reserve and increased comorbidities. Studies have shown that elder patients can have postoperative complication incidence up to 18%-32% and surgery-related mortality rate to 3.8%-9.5%. Therefore, elderly patients usually require more restrict operative injury control compared to the younger population. Surgical safety and effectiveness has become a crucial research focus for local advanced gastric cancer among elderly patients.

Laparoscopic gastrectomy is one of the standard treatments for early gastric cancer and has demonstrated its application value in local advanced gastric cancer. Two recent meta-analysis on observational studies have shown the feasibility of laparoscopic gastrectomy in elderly gastric cancer patients. Compared to conventional open resections, elderly patients may benefit from the advantages of laparoscopic approach such as less trauma, less blood loss, faster bowel movement recovery, earlier food intake, and shorter hospitalization. However, laparoscopic gastrectomy raises issues such as prolonged operation time and disturbance of circulatory and respiratory dynamics by carbon dioxide pneumoperitoneum during the procedure. Nonetheless, all currently available evidence comes from observational studies that are susceptible to bias and evidence on long-term survival is scarce. The investigators therefore proposed to conduct this randomized controlled trial comparing the feasibility and survival benefit of laparoscopic with open gastrectomy for elderly patients with local advanced gastric cancer. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Peking University Cancer Hospital & Institute
        • Sub-Investigator:
          • Xiangji Ying, M.P.H
        • Sub-Investigator:
          • Chao Gao, M.D.
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Laparoscopic gastrectomy
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
Patients will receive laparoscopic gastrectomy within one week after randomization.
Active Comparator: Open gastrectomy
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
Patients will receive open gastrectomy within one week after randomization.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative complication rate
Time Frame: within 30 days after surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of postoperative hospitalization stay
Time Frame: within 30 days after surgery
Postoperative hospitalization stay refers to the time interval between the day of surgery and discharge, and will be recorded by the investigators.
within 30 days after surgery
Postoperative life quality
Time Frame: one-year after surgery
Will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaires (i.e. QLQ-C30), which contains both QLQ-STO22 and ELD14 modules. This is a questionnaire developed to assess the generic and disease-specific quality of life for elderly gastric cancer patients by European Organisation for Research and Treatment of Cancer. The Summary Score will be calculated from the mean of scales. Prior to calculating the mean, the symptom scales will need to be reversed to obtain a uniform direction of all scales. The summary score should only be calculated if all of the required scale scores are available (using scale scores based on the completed items, provided that at least 50% of the items in that scale have been completed.
one-year after surgery
Three-year overall survival rate
Time Frame: Three-year after surgery
Overall survival is defined as the time interval from the time of the radical gastrectomy to the date of all-cause death or the last follow-up. Three-year overall survival rate will be calculated using the Kaplan-Meier Methods.
Three-year after surgery
Three-year disease-free survival rate
Time Frame: Three-year after surgery
Disease-free survival is defined as the time interval from the time of the radical gastrectomy to the date of the detection of cancer recurrence or the last follow-up. Three-year disease-free survival rate will be calculated using the Kaplan-Meier Methods.
Three-year after surgery
Postoperative pain
Time Frame: within 2 weeks after surgery
Postoperative pain will be measured using the Numeric Rating Scale (NRS-11) which is an 11-point scale for patient self-reporting of pain. The scale ranges from 0 to 10, with 0 being no pain. Pain level will be graded into four levels for analysis: "0: No Pain", "1-3: Mild Pain", "4-6 Moderate Pain", and "7-10 Severe Pain".
within 2 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ziyu Li, MD, Peking University Cancer Hospital and Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SF2018-4-2156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The deidentified datasets generated during the current study will be publicly available via an appropriate data archive 6 months after the completion of the trial.

IPD Sharing Time Frame

6 months after the completion of the trial

IPD Sharing Access Criteria

As request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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