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Heated chemo combo tested in abdominal cancer surgery
NCT ID NCT01226550
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a treatment for peritoneal carcinosis, a cancer that has spread to the lining of the abdomen from the stomach, bowel, or appendix. The approach combined surgery to remove visible tumors with heated chemotherapy drugs (mitomycin C and irinotecan) pumped directly into the abdomen during the operation. The trial enrolled 18 people and focused on finding safe drug doses and tracking side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mitomycin C and irinotecan (chemotherapy drugs)
- What this could lead to
- If this approach proves safe and effective, it could offer a treatment option for people with peritoneal cancer that has spread from the digestive system.
- What could go wrong
- This was a very small, early-phase study (18 people) focused on safety and dosing, not on curing the disease. The combination of major surgery and heated chemotherapy carries significant risks, including serious complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
18 people
The number who actually took part.
- Start date
-
Jun 2007
- Finished
-
Apr 2011
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 64 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Service de Chirurgie Générale et Thoracique, Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69495, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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