Adjuvant HIPEC to Prevent Colorectal Peritoneal Metastases in High-risk Patients

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Collaborator: Azienda Usl di Bologna
• Treatments: Cisplatin; Mitomycin; Mitomycins

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