Clinical trial · Interventional
Radical Gastrectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer
A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Gastric Cancer During Radical Gastrectomy
NCT02528110CI-TRIAL-00044210completedPhase 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 efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gastrectomy plus HIPEC is superior to only radical gastrectomy in terms of overall survival.
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 |
|---|---|---|---|
| Malignant Neoplasm of Stomach | Malignant Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D2 radical gastrectomy | Procedure | — | UNRESOLVED |
| Hyperthermic intraperitoneal chemotherapy (HIPEC) | Procedure | — | UNRESOLVED |
| SOX postoperative chemotherapy | Other | — | UNRESOLVED |
| XELOX postoperative chemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- SHAM_COMPARATOR
- label
- Radical gastrectomy without HIPEC
- description
- Patients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and postoperative chemotherapy (SOX or XELOX)
- interventionNames
- Procedure: D2 radical gastrectomy
- Other: SOX postoperative chemotherapy
- Other: XELOX postoperative chemotherapy
- type
- EXPERIMENTAL
- label
- Radical gastrectomy with HIPEC
- description
- Patients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (SOX or XELOX)
- interventionNames
- Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC)
- Procedure: D2 radical gastrectomy
- Other: SOX postoperative chemotherapy
- Other: XELOX postoperative chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histological proved diagnosis of locally advanced gastric cancer. * No evidence of distant metastases or peritoneal metastases. * Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with T3-T4 stage. * Eligible for radical gastrectomy with D2 lymphadenectomy. * Have not received cytotoxic chemotherapy or radiotherapy. * Written informed consent is obtained prior to commencement of trial treatment. Exclusion Criteria: * Existence of distant metastasis or peritoneal metastasis during surgery (M1). * Any previous chemotherapy or radiotherapy * Active systemic infections * Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial. * Female patients who are pregnant or breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.