Adjuvant HIPEC to Prevent Colorectal Peritoneal Metastases in High-risk Patients
Colorectal Neoplasm, Metastasis
About this trial
This is an interventional treatment trial for Colorectal Neoplasm focused on measuring HIPEC, peritoneal lavage
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Adjuvant HIPEC
Matched control
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.
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.