Clinical trial · Interventional
Clinical Analysis of HIPEC for T4 Colorectal Cancer After Surgery
Clinical Study of the Impact of Hyperthermic Intraperitoneal Chemotherapy on Peritoneal Recurrence and Prognosis of Patients With Stage T4 Colorectal Cancer After Radical Surgery: A Multicentre Randomised Clinical Trial
NCT03221608CI-TRIAL-00028670unknownPhase 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)
This multicentric study aims to determine if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to prevent the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment after surgery.
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 |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery and HIPEC with Lobaplatin | Procedure | — | UNRESOLVED |
| Surgery without HIPEC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- surgery alone(open/laparoscopic)
- description
- The patients with colorectal cancer (T4N0-2M0) who have a high risk of developing colorectal Peritoneal Carcinomatosis (PC) undergo curative surgery(open/laparoscopic).
- interventionNames
- Procedure: Surgery without HIPEC
- type
- EXPERIMENTAL
- label
- surgery and HIPEC
- description
- Standard surgical treatment and HIPEC with Lobaplatin.
- interventionNames
- Procedure: Surgery and HIPEC with Lobaplatin
Primary outcomes (1)
- measure
- Incidence of endoperitoneal recurrence at 36 months
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically-proven colorectal adenocarcinoma 2. Patients with colon cancer or intraperitoneal rectal cancer with clinical (by CT) T4 tumors, any N, M0 3. Signed informed consent 4. White blood cell count of at least 3000/mm3, platelet count of at least 100.000/mm3 5. No bleeding diathesis or coagulopathy 6. Patients without chemotherapy, radiation or other anti-cancer treatment before the clinical trial Exclusion Criteria: 1. Liver and/or lung metastases 2. Pregnant women or likely to be pregnant 3. Severe hepatic and / or renal dysfunction 4. Impossibility of an adequate follow-up 5. Without history of cancer during last 5 years 6. Other concurrent chemotherapy 7. Severe or uncontrolled mental illness 8. Patients with epilepsy required to be treated
References
Publications (0)
Data not yet available
No reference posted for this study.