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

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Neoadjuvant Chemotherapy
Laparoscopic gastrectomy
Open gastrectomy
Adjuvant Chemotherapy
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Locally advanced gastric cancer, Laparoscopic distal D2 gastrectomy, Neoadjuvant chemotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic gastrectomy

Open gastrectomy

Arm Description

Laparoscopic distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.

Open distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.
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.
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.

Full Information

First Posted
March 23, 2015
Last Updated
September 26, 2018
Sponsor
Peking University
Collaborators
Beijing Municipal Science & Technology Commission
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1. Study Identification

Unique Protocol Identification Number
NCT02404753
Brief Title
A Comparison of Laparoscopic With Open Distal Gastrectomy in Advanced Gastric Cancer After Neoadjuvant Chemotherapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (Actual)
Primary Completion Date
November 25, 2020 (Anticipated)
Study Completion Date
November 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
Collaborators
Beijing Municipal Science & Technology Commission

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Locally advanced gastric cancer, Laparoscopic distal D2 gastrectomy, Neoadjuvant chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic gastrectomy
Arm Type
Experimental
Arm Description
Laparoscopic distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.
Arm Title
Open gastrectomy
Arm Type
Active Comparator
Arm Description
Open distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Neoadjuvant Chemotherapy
Other Intervention Name(s)
NACT
Intervention Description
XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine 1000mg/m2,po.,Bid,d1-14; Repeat every 21 days for 3 courses.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic gastrectomy
Other Intervention Name(s)
LDG
Intervention Description
Laparoscopic distal gastrectomy with D2 lymph node dissection
Intervention Type
Procedure
Intervention Name(s)
Open gastrectomy
Other Intervention Name(s)
ODG
Intervention Description
Open distal gastrectomy with D2 lymph node dissection
Intervention Type
Drug
Intervention Name(s)
Adjuvant Chemotherapy
Other Intervention Name(s)
ACT
Intervention Description
XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine 1000mg/m2,po.,Bid,d1-14; Repeat every 21 days for 5 courses.
Primary Outcome Measure Information:
Title
3-year progression-free survival
Description
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
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
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
Time Frame
36 months
Title
Surgical morbidity
Description
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.
Time Frame
30 days
Title
Surgical mortality
Description
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.
Time Frame
30 days
Title
Postoperative recovery index
Description
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.
Time Frame
2 weeks
Title
Postoperative quality of life
Description
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.
Time Frame
Up to 1 year post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziyu Li, M.D.
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
30099396
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.
Results Reference
background
PubMed Identifier
27287914
Citation
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.
Results Reference
background
PubMed Identifier
31553463
Citation
Li Z, Shan F, Ying X, Zhang Y, E JY, Wang Y, Ren H, Su X, Ji J. Assessment of Laparoscopic Distal Gastrectomy After Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer: A Randomized Clinical Trial. JAMA Surg. 2019 Dec 1;154(12):1093-1101. doi: 10.1001/jamasurg.2019.3473.
Results Reference
derived

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

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