Clinical trial · Interventional
D2 and D2+ Radical Surgery for the Treatment of Advanced Distal Gastric Cancer
Phase 2 Study of D2 and D2+ Radical Surgery for the Treatment of Advanced Distal Gastric Cancer
NCT01836991CI-TRIAL-00010115unknownPhase 2ClinicalTrials.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 purpose of this study is to evaluate the safety and the effect of D2 and D2+ radical surgery for the treatment of advanced distal gastric cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- D2 surgery
- description
- D2 surgery(No.1、No.3、No.4sb、No.4d、No.5、No.6、No.7 and No.8a、No.9、No.11p、No.12a lymph node)
- interventionNames
- Procedure: surgery
- type
- EXPERIMENTAL
- label
- D2+ surgery
- description
- D2+ surgery(D2+8p、12b、13、14v lymph node)
- interventionNames
- Procedure: surgery
Primary outcomes (2)
- measure
- the disease-free survival time
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female aged 18 to 70 years old. * The preoperative evaluation: distal gastric cancer patients, ≥ T2 or N +; or staging II, IIIA, IIIB. * Karnofsky score ≥ 70, life expectancy \> 6 months. * Endoscopic biopsy diagnosis of gastric cancer, excluding non-Hodgkin's lymphoma, leiomyosarcoma and other mesenchymal tumors. * the blood and biochemical indicators of the subjects must meet the following criteria: Hb ≥ 9 g / dl; WBC ≥ 4,000 / mm3, ≤ 12000 / mm3; PLT ≥ 100,000/mm3; * GOT, GPT within twice the institutional limit,serum total bilirubin \< 1.5 times the upper limit of normal, serum creatinine\< 1.25 times the upper limit of normal * have not received prior chemotherapy, radiotherapy and biological therapy. signed informed consent. * must accept the standard D2 or D2 + radical gastrectomy. * with good compliance. Exclusion Criteria: * pregnancy, breast-feeding women. * allergy with chemotherapy drugs or metabolic disorder. * the history of organ transplants (including bone marrow transplantation and autologous peripheral stem cell transplantation). * had long received systemic steroid treatment (Note: short-term users of withdrawal \> 2 weeks can be selected.) * The existence of the peripheral nervous system disorders or significant neurological disorders and a history of central nervous system disorders. * patients with severe infection requires treatment. * patients associated with dysphagia, active peptic ulcer, incompleteness intestinal obstruction, active gastrointestinal bleeding, perforation. severe liver disease (such as cirrhosis), kidney disease, respiratory disease or uncontrollable diabetes. * with other malignancies which were not cured. * EKG abnormalities or heart disease with apparent clinical symptoms, including congestive heart failure, coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction. Coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction.
References
Publications (2)
- DERIVEDXu ZY, Hu C, Chen S, Du YA, Huang L, Yu PF, Wang LJ, Cheng XD. Evaluation of D2-plus radical resection for gastric cancer with pyloric invasion. BMC Surg. 2019 Nov 20;19(1):172. doi: 10.1186/s12893-019-0605-6. PMID 31747885
- DERIVEDYu P, Du Y, Xu Z, Huang L, Cheng X. Comparison of D2 and D2 plus radical surgery for advanced distal gastric cancer: a randomized controlled study. World J Surg Oncol. 2019 Feb 6;17(1):28. doi: 10.1186/s12957-019-1572-1. PMID 30728027