Clinical trial · Interventional
The Long-term Effect of D4 Lymphadenectomy for Gastric Cancer
The Long-term Effect of D4 Lymphadenectomy for Gastric Cancer: a Multicenter, Open-label, Randomized Trial
NCT02423278CI-TRIAL-00017604unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Effects of Chemotherapy | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radical Gastrectomy Plus D2 Lymphadenectomy | Procedure | — | UNRESOLVED |
| Radical Gastrectomy Plus D4 Lymphadenectomy | Procedure | — | UNRESOLVED |
| S-1+Oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- D4 Lymphadenectomy
- description
- This 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.
- interventionNames
- Procedure: Radical Gastrectomy Plus D4 Lymphadenectomy
- Drug: S-1+Oxaliplatin
- type
- EXPERIMENTAL
- label
- D2 Lymphadenectomy
- description
- This 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.