Clinical trial · Interventional
Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer
NCT02672865CI-TRIAL-00038105completedPhase 1ClinicalTrials.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 determine safety and feasibility of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with mitomycin and cisplatin in patients with locally advanced gastric cancer undergoing standard surgical resection. Patients will be treated with HIPEC using a single dose of mitomycin 15mg/m2 and cisplatin 50mg/m2 at 41-42 C for 90 minutes, during the definitive surgical resection for gastric cancer. HIPEC will be performed after resection but before anastomosis.
Conditions
Conditions (2)
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 |
| Locally Advanced Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperthermic Intraperitoneal Chemotherapy (HIPEC) | Drug | Hyperthermic Intraperitoneal Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HIPEC
- description
- The administration of hyperthermic intraperitoneal chemotherapy (HIPEC), using a warm solution of two chemotherapy medications (mitomycin and cisplatin) to bathe the internal surfaces of the abdomen in an attempt to kill any microscopic cancer cells that might be present on these surfaces.
- interventionNames
- Drug: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Primary outcomes (1)
- measure
- Post Operative Complications
- timeFrame
- 90 days following surgery
- description
- Patients will be followed for 90 days following surgery. Postoperative complications will be recorded and graded according to the modified Clavien-Dindo classification.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients aged 18-75 with biopsy-proven gastric adenocarcinoma 2. Tumor clinically staged T3 or T4 and/or nodes staged clinically positive 3. ECOG performance status \< 2 Exclusion Criteria: 1. Distant metastases 2. Peritoneal carcinomatosis 3. Synchronous malignancy 4. Tumors at the gastroesophageal junction 5. Recurrent gastric adenocarcinoma 6. Creatinine \>/= 1.5 7. Bilirubin \>/= 2 8. INR \>/= 2 9. Allergy to drugs included in the treatment plan 10. Pregnancy 11. Contraindication to major surgery
References
Publications (2)
- RESULTSeshadri RA, Glehen O. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in gastric cancer. World J Gastroenterol. 2016 Jan 21;22(3):1114-30. doi: 10.3748/wjg.v22.i3.1114. PMID 26811651
- RESULTSuo T, Mahteme H, Qin XY. Hyperthermic intraperitoneal chemotherapy for gastric and colorectal cancer in Mainland China. World J Gastroenterol. 2011 Feb 28;17(8):1071-5. doi: 10.3748/wjg.v17.i8.1071. PMID 21448361