Clinical trial · Interventional
Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer
Phase II Pilot Study to Reduce the Incidence of Peritoneal Carcinoma After Curative Gastrectomy of Gastric Carcinoma or Adenocarcinoma of Gastroesophageal Transition by Hyperthermic Intraperitoneal Chemoperfusion
NCT04180761CI-TRIAL-00088092ProPeCwithdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No partecipants Enrolled
Summary
Brief summary (as posted)
This study investigates the effect of a combined therapy with gastrectomy and HIPEC in localized advanced 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 Neoplasms | Gastric Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HIPEC-Treatment
- description
- Doxorubicin (15 mg/m²/body surface) Cisplatin (75 mg/m²/body surface) applied as hyperthermic intraperitoneal chemotherapy (HIPEC) at 42.5°C for 60 minutes after the gastrectomy. All drugs used are approved.
- interventionNames
- Drug: intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)
Primary outcomes (1)
- measure
- Incidence of peritoneal metastases and proportion of patients free from peritoneal metastasis after one year after HIPEC.
- timeFrame
- one year
- description
- The primary objective of the study is to estimate the effect of a combined therapy with gastrectomy and HIPEC in localized advanced gastric cancer. The primary target is the incidence of peritoneal metastases in CT and the proportion of patients who after one year are free from peritoneal metastasis. The study is intended to provide planning data for a subsequent Phase III study in the form of an RCT.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent of the patient * Positive lavage cytology in staging laparoscopy * Intraoperative R0- or R1-gastrectomy (Re-evaluation intraoperative) * Histologically confirmed locally advanced, resectable Adenocarcinomas of the stomach (incl. AEG II-III): \>cT3 and/or cN+ and cM0 (none existing solid Peritoneal metastases, Re-evaluation intraoperative) * Neoadjuvant chemotherapy ≥ 2 cycles Exclusion Criteria: * \< 18 years * Existence of contraindications or contraindications against the study medication * Uncompensated Heart Failure (NYHA III and IV) * Severe CHD, medically insufficient treatable cardiac arrhythmias, uncontrolled arterial hypertension * Serum creatinine ≥ 1.5 x the standard value or a Creatinine clearance \< 60 ml/min/1.73 m2 * Severe pulmonary dysfunction (COPD, PAH), Pulmonary function test confirmed (IVC \< 55 %, DLCO \< 40%) * malignant secondary tumor disease that persists for \< 5 years (Exception: in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin) * Participation in other interventional studies that at the time of the ProPeC study inclusion, still are not finished * pregnancy or lactation
References
Publications (0)
Data not yet available
No reference posted for this study.