Clinical trial · Interventional
Feasibility of Intraperitoneal Chemotherapy in the Surgical Treatment of Colon Cancer cT4
NCT03561948CI-TRIAL-00050790completedN/AClinicalTrials.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 is a randomised controlled study aims to determine the oncological effectiveness of adjuvant HIPEC, using intraperitoneal Mytomicin C following a curative resection of a cT4 Colon cancer in preventing the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control group | Procedure | — | UNRESOLVED |
| Experimental group | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Surgery and Intraperitoneal Chemotherapy
- interventionNames
- Procedure: Experimental group
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- only surgery
- interventionNames
- Procedure: Control group
Primary outcomes (1)
- measure
- Positive peritoneal lavage
- timeFrame
- through study completion, an average of 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Colon cancer which represent cT4N0-2 M0 on the basis of preoperative examination data (CT of the chest, abdominal and pelvic organs) in line with The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual: 2. Histologically verified adenocarcinoma of the colon. 3. Signed informed consent. Exclusion Criteria: 1. Pregnancy or lactation. 2. The presence of synchronous or metachronous malignant tumors. 3. Distant metastases to the liver, lungs, peritoneal carcinomatosis and other organs. 4. Neoadjuvant chemotherapy. 5. Suspected Lynch syndrome.
References
Publications (0)
Data not yet available
No reference posted for this study.