Clinical trial · Interventional
Adjuvant HIPEC to Prevent Colorectal Peritoneal Metastases in High-risk Patients
Pilot Study of Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Colorectal Cancer at High Risk for the Development of Metachronous Peritoneal Metastases
- 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 prognosis of peritoneal metastases from colorectal cancer has recently improved with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). Although outcomes are further improved when early stage peritoneal metastases are treated, adjuvant HIPEC has not yet been thoroughly addressed. This prospective pilot study assessed feasibility, safety and efficacy of HIPEC performed simultaneously with primary curative surgery in colorectal cancer patients with primary tumor-related risk-factors for the development of metachronous peritoneal metastases.
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 |
|---|---|---|---|
| Colorectal Neoplasm | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant HIPEC | Drug | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adjuvant HIPEC
- description
- Adjuvant HIPEC will be performed simultaneously with primary tumor resection in patients undergoing curative surgery for primary colorectal cancer associated with risk factors for the development of metachronous peritoneal metastases.
- interventionNames
- Drug: adjuvant HIPEC
- Procedure: surgery
- type
- NO_INTERVENTION
- label
- Matched control
- description
- Comparable controls will be retrospectively selected from patients undergoing curative surgery for colorectal cancer at the National Cancer Institute (Milan, Italy) during the same period. Every single control patient will be matched with a.patient in HIPEC group according to the following criteria: i) risk-factor for metachronous PM (minimal synchronous PM vs. ovarian metastases vs. pathological tumor \[pT\] stage (pT4a/b); ii) pathological node (pN) stage (pN0 vs. pN1/2); iii) grading (well/moderately vs. poorly differentiated); iv) histological subtype (adenocarcinoma vs. mucinous/signet ring cell carcinoma); v) sex; vi) age (+/-5 years). The investigators will be blinded to patient outcomes during the process.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * pathologically confirmed colorectal carcinoma; * curative surgery; * presence of at least one of the following risk-factors for the development of metachronous PM: * minimal synchronous PM (nodules ≤1cm in the omentum and/or close to the primary tumor), completely resected at the same time as primary tumor; * synchronous ovarian metastases, also resected at the same time as primary tumor; * primary tumor either penetrating visceral peritoneum (T4a), * primary tumor directly invading other organs (T4b); * signature of an informed consent form. * intention to start adjuvant systemic therapy and postoperative follow-up; * performance status ≤2 according to the Eastern Cooperative Oncology Group score; * no significant co-morbidities. * no active sepsis * no impaired cardiac function (history of previous cardiac failure, or ejection fraction \<40%) * no impaired renal function (serum creatinin \> 1.5 normal value or creatinin clearance \< 60 mL/min); * no impaired hepatic function (serum glutamic oxaloacetic transaminase, serum glutamic pyruvic transaminase, bilirubin \> 1.5 normal value); * no impaired bone marrow function (leucocytes \< 4000/mm3 ; neutrophils \< 1500/mm3; platelet \< 80000/mm3) * no impaired lung function (diagnosis of severe chronic obstructive pulmonary disease , or forced expiratory volume at one second \< 50% or a diffusion capacity of lung for carbon monoxide \< 40% age adjusted). Exclusion Criteria: * extensive PM (nodules \>1cm, and/or nodules outside the omentum and/or beyond the close vicinity of the primary tumor); * extra-abdominal/hepatic metastases; * emergency presentation (bleeding, perforated, or occlusive primary); * bleeding diathesis or coagulopathy * history of previous neoplasm during the past three years, excluding skin spinocellular/basocellular carcinoma; * preoperative pelvic radio-chemotherapy
References
Publications (2)
- RESULTVirzi S, Iusco D, Baratti D, Bonomi S, Grassi A, Kusamura S, Deraco M. Pilot study of adjuvant hyperthermic intraperitoneal chemotherapy in patients with colorectal cancer at high risk for the development of peritoneal metastases. Tumori. 2013 Sep-Oct;99(5):589-95. doi: 10.1177/030089161309900505. PMID 24362862
- DERIVEDBaratti D, Kusamura S, Iusco D, Gimondi S, Pietrantonio F, Milione M, Guaglio M, Bonomi S, Grassi A, Virzi S, Leo E, Deraco M. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at the Time of Primary Curative Surgery in Patients with Colorectal Cancer at High Risk for Metachronous Peritoneal Metastases. Ann Surg Oncol. 2017 Jan;24(1):167-175. doi: 10.1245/s10434-016-5488-5. Epub 2016 Aug 12. PMID 27519353