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NCT Number: NCT01226550

Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan

This is an open, non-randomized, phase I-II, pilot study, which evaluates the combination of optimum cytoreductive surgery and hyperthermic intraoperative peritoneal chemotherapy (HIPEC) with mitomycin C (MMC) and irinotecan. The latter drug will be administered in escalating doses to patients with gastric, colorectal, appendicular, or primary peritoneal carcinosis (PC).

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Key information

Conditions

Peritoneal Carcinosis (PC) Abdominal Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Service de Chirurgie Générale et Thoracique, Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a peritoneal carcinosis (PC) either of digestive origin or primary: a colorectal or gastric carcinosis, a peritoneal pseudomyxoma or mesothelioma, or a primary carcinosis of the peritoneum regardless the number of prior treatment lines.
  • A PC and primary tumor considered to be resectable according to preoperative clinical and paraclinical data: absence of mesenteric retraction and absence of bladder invasion.
  • Patients in good general health (ASA ≤ 2).
  • Absence of cardiorespiratory failure (PaO2 > 60 mmHg in a stable condition, dyspnea ≤ NYHA stage 1, left ventricular ejection fraction > 60%.).
  • Prothrombin level >70 %, total bilirubin < 2 x the normal level, ASAT and ALAT < 2.5 x normal levels, and alkaline phosphatases < 5 x normal levels.
  • Creatinine clearance > 60 ml/min, polynuclear neutrophils > 1500/mm3, and a white blood cell count > 4000 /mm3.
  • Patients who give written, informed consent.
  • Patients affiliated with the French universal healthcare system.

Exclusion criteria

  • Patients with a PC with ovarian, mammary, biliary, pancreatic, or bronchial origin.
  • Evolutive patients after systemic chemotherapy.
  • Patients with a PC considered to be irresectable according to preoperative clinical and paraclinical data: mesenteric retraction or bladder invasion.
  • Patients in poor general health (ASA > 2).
  • Cardiorespiratory failure (dyspnea > NYHA stage 1, PaO2 < 60 mmHg in a stable condition)
  • Prothrombin level < 70 %.
  • Any brain abnormality showing on the head scan.
  • Signs of heart failure and especially left ventricular ejection fraction < 60% on the cardiac ultrasound.
  • Thrombocytopenia < 100 000 / mm3
  • Visceral metastases other than a single resectable liver metastasis.
  • Pregnancy or breast feeding.
  • Chronic inflammatory intestinal disease and/or an intestinal obstruction.
  • History of severe hypersensitivity to irinotecan hydrochloride trihydrate or one of the excipients of Campto.
  • Bilirubinemia > 3 times the normal upper limit
  • Yellow fever vaccine.
  • Prophylactic treatment with phenytoin.
  • Severe medullary insufficiency.

Treatment and study plan

Cytoreductive surgery and HIPEC

Procedure

The most complete cytoreductive surgery possible (ideally macroscopically complete) followed by a closed-abdomen hyperthermic intraoperative peritoneal chemotherapy (HIPEC), using a closed circuit connected to the self-regulating Cavitherm machine (EEC certified). This perfusion apparatus records temperature, flow, and pressure for 90 minutes at real temperature (42-43°C).

The dialysate is made up of peritoneal dialysis fluid containing 0.7 mg/kg of MMC and increasing doses of irinotecan added to the dialysate the last 30 minutes of the HIPEC.

Potentiation of irinotecan using an intravenous FUFOL perfusion at least 1hour before HIPEC (1st dose level: 10 mg/m² of folinic acid, then 200 mg/m² of 5-FU; 2nd dose level: 20 mg/m² of folinic acid, then 400 mg/m² of 5-FU).

Primary outcomes

  1. Morbidity rate

    Time frame: 30 days postoperative

    postoperative complications (class III and IV, Common Terminology Criteria V3; National Cancer Institute)

Secondary outcomes

  1. Mortality rate

    Time frame: 30 days postoperative

  2. Intraperitoneal and serumal concentration (pharmacokinetics) of mitomycine C, irinotecan, and its metabolites.

    Time frame: per-HIPEC

    Plasma, peritoneal, and urinary values for MMC, irinotecan, SN-38, SN-38G, APC, and NPC.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Oct 22, 2010
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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