The Long-term Effect of D4 Lymphadenectomy for Gastric Cancer
1 other identifier
interventional
200
1 country
1
Brief Summary
The main purpose of this study is to evaluate the effect of extensive lymphadenectomy procedure in treatment of gastric cancer. This study is designed as a open-label, multi-centers, randomized controlled trial. The overall survival and free disease survival are primary outcomes, with postoperative complication, hospital charges, and life quality as secondary outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 gastric-cancer
Started Jan 2010
Longer than P75 for phase_2 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 13, 2015
CompletedFirst Posted
Study publicly available on registry
April 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedApril 22, 2015
April 1, 2015
6.4 years
April 13, 2015
April 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Survival
five years after surgery
Relapse-free Survival
five years after surgery
Secondary Outcomes (4)
Early complications
within the first 30 days after surgery
Perioperative mortality
within the first 30 days after surgery
Life quality measured by HRQOL score
five years after surgery
Length of Hospital stay
an expected average of 4 weeks after admission
Study Arms (2)
D4 Lymphadenectomy
EXPERIMENTALThis is the interventional group in which additional para-aortic lymph nodes are dissected meanwhile. Under this arm, main therapeutic measures are listed as follows: * three-cycle SOX chemo regimen (S-1+Oxaliplatin) as neoadjuvant chemotherapy * radical gastrectomy plus D4 lymphadenectomy * five-cycle SOX chemo as adjuvant chemotherapy * five-year follow-up program to evaluate the prognosis.
D2 Lymphadenectomy
EXPERIMENTALThis is the control group in which a classic surgical procedure for gastric cancer is performed. Under this arm, main therapeutic measures are included as follows: * three-cycle SOX chemo regimen (S-1+Oxaliplatin) as neoadjuvant chemotherapy * radical gastrectomy plus D2 lymphadenectomy (Without para-aortic lymph nodes dissection) * five-cycle SOX chemo as adjuvant chemotherapy * five-year follow-up program to evaluate the prognosis.
Interventions
This surgical procedure is performed by the same high-experienced surgical team as the control arm. All lymph nodes around stomach (station 1\&2 LNs) must be removed to achieve a radical lymphadenectomy. Para-aortic lymph nodes should not be dissected even if a suspected lymph node metastasis is diagnosed from radiographic exams.
This surgical procedure is also performed by the same high-experienced surgical team as the control arm. Lymph nodes around stomach (station 1\&2 LNs) and para-aortic lymph nodes must be removed during the operation.
A perioperative chemotherapy, known as SOX regimen, should be performed in each enrolled patient with three-cycle treatments followed after a pathological carcinoma diagnosis. After a radical operation (arm groups), additional five-cycle treatments of adjuvant chemotherapy (SOX regimen) would be performed, followed by follow-up program. The treatment bundles are listed as follows: * S-1: 40\~60mg bid，po, Day1\~14 （S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid） * Oxaliplatin: 130mg/m2，iv drip for 2h，Day1
Eligibility Criteria
You may qualify if:
- The informed consent has been obtained from the patient.
- With confirmed pathological diagnosis of gastric cancer and visible para-aortic lymph nodes metastasis.
- Endurable D2/D4 gastrectomy and neoadjuvant chemotherapy.
- With moderate/good ECOG health rating (PS): 0-1 score.
You may not qualify if:
- Pregnant woman or lactating woman.
- With confirmed distant metastasis in liver, lung, bones, or other organs.
- Intolerable operation or neoadjuvant chemotherapy.
- With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
- With bad compliance or contraindication to enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yulong He, MD
First Affiliated Hospital, Sun Yat-Sen University
Central Study Contacts
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
- Director of Center of Gastrointestinal Surgery
Study Record Dates
First Submitted
April 13, 2015
First Posted
April 22, 2015
Study Start
January 1, 2010
Primary Completion
June 1, 2016
Study Completion
December 1, 2020
Last Updated
April 22, 2015
Record last verified: 2015-04