Clinical trial · Interventional
A Clinical Trial of D1+ Versus D2 Distal Gastrectomy for Stage IB & II Advanced Gastric Cancer
A Multicenter Randomized Clinical Trial of D1+ Versus D2 Distal Gastrectomy for Stage IB & II Advanced Gastric Cancer
NCT02144727CI-TRIAL-00021854ADDICTunknownPhase 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)
In oncological aspect, D1+ lymph node dissection would be enough for early stage gastric cancer in advanced gastric cancer (stage IB/IIA/IIB ).
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 Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D1+ distal subtotal gastrectomy | Procedure | — | UNRESOLVED |
| D2 distal subtotal gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- D2 distal subtotal gastrectomy
- description
- D2 distal subtotal gastrectomy D2 includes Nos.1.3,4sb,4d,5,6,7,8a,9,11p,and 12a nodes in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy
- interventionNames
- Procedure: D2 distal subtotal gastrectomy
- type
- EXPERIMENTAL
- label
- D1+ distal subtotal gastrectomy
- description
- D1+ distal subtotal gastrectomy D1+ includes Nos.1,3,4sb,4d,5,6,7,8a,and 9 nodes in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy
- interventionNames
- Procedure: D1+ distal subtotal gastrectomy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria : * Histologically proven primary gastric adenocarcinoma * T1N1, T2N0, T2N1, T3N0, T3N1 by CT scan (AJCC 7th classification) and intraoperative surgical staging prior to resectional procedure * Location of primary tumor; antrum, or angle, lower body or mid body of the stomach * No evidence of other distant metastasis * Aged ≥ 20 year old * Performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale * No prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection * Adequate organ functions defined as indicated below: * WBC 3000/mm3 - 12,000/mm3 * \>serum Hemoglobin 8.0 g/dl * \> serum Platelet 100 000/mm3 * \< serum AST 100 IU/l * \<serum ALT 100 IU/l * \< Total Bilirubin 2.0 mg/dl * Written signed informed consent Exclusion Criteria : * Active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) * Gastric remnant cancer * ≥T4a in surgical staging before resection * N2 or more (number of metastatic lymph nodes ≥3) in CT scan * Histologically rare variants in WHO Classification such as Adenosquamous, Hepatoid, Squamous cell, Undifferentiated, , neuroendocrine carcinoma and others * Pregnant or breast-feeding women * Mental disorder(diagnosed with mental disorder on medical record) * systemic administration of corticosteroids(include Herbal Medication) * unstable angina or myocardial infarction within 6 months of the trial * unstable hypertension * severe respiratory disease requiring continuous oxygen therapy * previous upper abdominal surgery except laparoscopic cholecystectomy
References
Publications (0)
Data not yet available
No reference posted for this study.