A Comparison of Laparoscopic With Open Distal Gastrectomy in Advanced Gastric Cancer After Neoadjuvant Chemotherapy (REALIZATION)
September 26, 2018 updated by: Ziyu Li, MD, Peking University
A Randomized, Single Center, Controlled Phase II Study to Compare Laparoscopic Versus Open Distal Gastrectomy in Locally Advanced Gastric Cancer After Neoadjuvant Chemotherapy
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
102
Phase
- 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 Locations
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Beijing
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Beijing, Beijing, China, 100142
- Peking University Cancer Hospital
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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
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Laparoscopic gastrectomy
Laparoscopic distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.
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XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine
1000mg/m2,po.,Bid,d1-14;
Repeat every 21 days for 3 courses.
Other Names:
Laparoscopic distal gastrectomy with D2 lymph node dissection
Other Names:
XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine
1000mg/m2,po.,Bid,d1-14;
Repeat every 21 days for 5 courses.
Other Names:
|
|
ACTIVE_COMPARATOR: Open gastrectomy
Open distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.
|
XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine
1000mg/m2,po.,Bid,d1-14;
Repeat every 21 days for 3 courses.
Other Names:
XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine
1000mg/m2,po.,Bid,d1-14;
Repeat every 21 days for 5 courses.
Other Names:
Open distal gastrectomy with D2 lymph node dissection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
3-year progression-free survival
Time Frame: 36 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival
Time Frame: 36 months
|
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
|
|
Surgical morbidity
Time Frame: 30 days
|
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.
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30 days
|
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Surgical mortality
Time Frame: 30 days
|
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.
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30 days
|
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Postoperative recovery index
Time Frame: 2 weeks
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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.
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2 weeks
|
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Postoperative quality of life
Time Frame: Up to 1 year post-operative
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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.
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Up to 1 year post-operative
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ziyu Li, M.D., Peking University Cancer Hospital & 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
- 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.
- 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.
- 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.
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)
April 1, 2015
Primary Completion (ANTICIPATED)
November 25, 2020
Study Completion (ANTICIPATED)
November 25, 2022
Study Registration Dates
First Submitted
March 23, 2015
First Submitted That Met QC Criteria
March 30, 2015
First Posted (ESTIMATE)
March 31, 2015
Study Record Updates
Last Update Posted (ACTUAL)
September 28, 2018
Last Update Submitted That Met QC Criteria
September 26, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GISCA2015001/LAP
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