Clinical trial · Interventional
Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer
NCT01683864CI-TRIAL-00031435HIPECStomachterminatedPhase 2 / Phase 3Results postedClinicalTrials.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): Recruitment problems
Summary
Brief summary (as posted)
Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer
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 |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| positive cytology with HIPEC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- positive cytology with HIPEC
- description
- gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative
- interventionNames
- Drug: positive cytology with HIPEC
- type
- NO_INTERVENTION
- label
- positive cytology without HIPEC
- description
- gastric cancer cytology positive without HIPEC
- type
- NO_INTERVENTION
- label
- negative cytology without HIPEC
- description
- gastric cancer with negative cytology
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven gastric adenocarcinoma: uT1,uT2, uT3, Nx, M0 2. No prior chemotherapy 3. Patients of full age, independent of gender ECOG ≤ 2 4. No dissemination of the tumor confirmed by CT of the lung and the abdomen. 5. Signed Consent form of the Patient agreeing to investigations 6. Leucocytes \> 3.000/µl 7. Thrombocytes \> 100.000/µl 8. Creatinine ≤ 1.5mg/dl and or Clearance \> 60 ml/min 9. informed consent of the patient 10. normal ejection-fraction of the heart Exclusion Criteria: 1. Dissemination of the tumor or non-resectable primary tumor 2. Malignant secondary disease \< 5 years in the past (Exception: in-situ-carcinoma of the cervix and appropriately treated basal cell carcinoma of the skin) 3. Patient not of full age 4. Inflammatory chronic bowel disease 5. Inclusion of the patient in a different study 6. Pregnancy or lactation
References
Publications (0)
Data not yet available
No reference posted for this study.