Clinical trial · Interventional
Chemotherapy Alone Versus Surgery Plus Chemotherapy for Distal Gastric Cancer With One Non-curable Factor
A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial of Chemotherapy Alone Versus D2 Gastrectomy and Metastasectomy Plus Chemotherapy for Distal Gastric Cancer With One Non-curable Factor
NCT03399253CI-TRIAL-00031188unknownPhase 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)
Our study aims to compare the efficacy and safety of Chemotherapy Alone Versus D2 distal gastrectomy and metastasectomy plus Chemotherapy for gastric cancer (GC) with one non-curable Factor
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Drug | Chemotherapy | ALIAS |
| surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- description
- chemotherapy with capecitabine and oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease
- interventionNames
- Drug: chemotherapy
- type
- EXPERIMENTAL
- label
- Surgery+Chemotherapy
- description
- D2 Gastrectomy and Metastasectomy + chemotherapy with capecitabine and oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease
- interventionNames
- Procedure: surgery
- Drug: chemotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Lower age limit of research subjects 18 years old and upper age limit of 75 years old. 2. PS (ECOG) of 0 or 1. 3. Without any other malignancies. 4. Written informed consent from the patient. 5. Standard gastrectomy with D2 lymphadenectomy for primary cancer 6. A single non-curable factor was defined by preoperative CT : hepatic metastasis (H1 or H2; maximum diameter ≤4 cm, number ≤4); peritoneal metastasis (R0 or R1 resection) para-aortic lymph node metastasis (number ≤4) ovarian metastasis adrenal metastasis renal metastasis 7. No contraindications to chemotherapy, including normal peripheral blood routine, liver and kidney function and electrocardiogram (WBC≥4.0 x 109 /L, NEU≥1.5 x 109 /L,PLT≥100 x 109 /L and HGB≥90g/L) Exclusion Criteria: 1. Female in pregnancy or lactation. 2. Supraclavicular lymph nodes metastases,lung and bone metastases. 3. Massive ascites or cachexia. 4. Extensive cancer metastases of liver, peritoneal metastasis,para-aortic lymph node 5. Patients participating in any other clinical trails currently,or participated in other trails within 1 months. 6. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases. 7. Poor treatment compliance of patients 8. The group of chemotherapy alone accepts gastrectomy for bleeding or obstruction 9. Failure of R0 or R1 metastasectomy and gastrectomy with D2 lymphadenectomy
References
Publications (0)
Data not yet available
No reference posted for this study.