Back to results

Laparoscopic Versus Open Gastrectomy for Elderly Local Advanced Gastric Cancer Patients

Primary Purpose

Advanced Gastric Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Laparoscopic gastrectomy

Open gastrectomy

About this trial

This is an interventional treatment trial for Advanced Gastric Cancer focused on measuring Elderly patients, Open gastrectomy, Laparoscopic gastrectomy

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Peking University Cancer Hospital & InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic gastrectomy

Open gastrectomy

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Length of postoperative hospitalization stay

Postoperative hospitalization stay refers to the time interval between the day of surgery and discharge, and will be recorded by the investigators.

Postoperative life quality

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.

Three-year overall survival rate

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 disease-free survival rate

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.

Postoperative pain

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".

Full Information

NCT ID

NCT03564834

First Posted

May 14, 2018

Last Updated

September 26, 2018

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT03564834

Brief Title

Laparoscopic Versus Open Gastrectomy for Elderly Local Advanced Gastric Cancer Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 23, 2018 (Actual)

Primary Completion Date

July 30, 2020 (Anticipated)

Study Completion Date

July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Gastric Cancer

Keywords

Elderly patients, Open gastrectomy, Laparoscopic gastrectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Laparoscopic gastrectomy

Arm Type

Experimental

Arm Description

Arm Title

Open gastrectomy

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic gastrectomy

Intervention Description

Patients will receive laparoscopic gastrectomy within one week after randomization.

Intervention Type

Procedure

Intervention Name(s)

Open gastrectomy

Intervention Description

Patients will receive open gastrectomy within one week after randomization.

Primary Outcome Measure Information:

Title

Postoperative complication rate

Description

Time Frame

within 30 days after surgery

Secondary Outcome Measure Information:

Title

Length of postoperative hospitalization stay

Description

Postoperative hospitalization stay refers to the time interval between the day of surgery and discharge, and will be recorded by the investigators.

Time Frame

within 30 days after surgery

Title

Postoperative life quality

Description

Time Frame

one-year after surgery

Title

Three-year overall survival rate

Description

Time Frame

Three-year after surgery

Title

Three-year disease-free survival rate

Description

Time Frame

Three-year after surgery

Title

Postoperative pain

Description

Time Frame

within 2 weeks after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fei Shan, MD

Phone

0086-10-88196606

shanfei@hsc.pku.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Ziyu Li, MD

Phone

0086-10-88196605

ziyu_li@hsc.pku.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ziyu Li, MD

Organizational Affiliation

Peking University Cancer Hospital and Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University Cancer Hospital & Institute

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fei Shan, M.D.

Phone

86-010-8819-6606

shanfei@hsc.pku.edu.cn

First Name & Middle Initial & Last Name & Degree

Ziyu Li, M.D.

Phone

86-010-8819-6605

ziyu_li@hsc.pku.edu.cn

First Name & Middle Initial & Last Name & Degree

Jiafu Ji, M.D.

First Name & Middle Initial & Last Name & Degree

Ziyu Li, M.D.

First Name & Middle Initial & Last Name & Degree

Fei Shan, M.D.

First Name & Middle Initial & Last Name & Degree

Xiangji Ying, M.P.H

First Name & Middle Initial & Last Name & Degree

Chao Gao, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

30445943

Citation

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.

Results Reference

derived

Learn more about this trial

Laparoscopic Versus Open Gastrectomy for Elderly Local Advanced Gastric Cancer Patients

We'll reach out to this number within 24 hrs