Could chemo around surgery beat cancer spread in the belly?
NCT ID NCT02758951
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether giving chemotherapy before and after surgery (plus heated chemo directly into the abdomen) helps people with colorectal cancer that has spread to the lining of the abdomen live longer. About 358 adults with resectable disease are randomly assigned to either the chemo-plus-surgery group or surgery alone. The main goal is to see if the combined approach improves overall survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemotherapy (CAPOX, FOLFOX, FOLFIRI, or fluoropyrimidine monotherapy)
- What this could lead to
- If it works, this could show that adding chemotherapy around surgery helps people with colorectal cancer that has spread to the abdomen live longer.
- What could go wrong
- This is a mid-to-late stage trial, but results are not yet available. Chemotherapy can cause side effects, and the added treatment may not improve survival compared to surgery alone.
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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358 people
The number who actually took part.
- Started
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Jun 2017
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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.
Eligible patients are adults who have: * a World Health Organisation (WHO) performance status of ≤1; * histological or cytological proof of PM of a non-appendiceal colorectal adenocarcinoma with ≤50% of the tumour cells being signet ring cells; * resectable disease determined by a diagnostic laparoscopy/laparotomy in combination with abdominal computed tomography and/or magnetic resonance imaging (MRI); only in patients in whom diagnostic laparoscopy or laparotomy is considered not feasible or valuable (e.g. due to known adhesions impeding adequate PCI scoring), it is also allowed to determine resectability by CT or MRI only (provided that the colorectal PM are histologically or cytologically proven); * no evidence of systemic colorectal metastases within three months prior to enrolment; * no systemic therapy for colorectal cancer within six months prior to enrolment; * no contraindications for CRS-HIPEC; * no previous CRS-HIPEC; * no concurrent malignancies that interfere with the planned study treatment or the prognosis of resected colorectal PM. Importantly, enrolment is allowed for patients with radiologically non-measurable disease. Enrolment is also allowed for patients who are referred to a study centre after a macroscopically complete resection of colorectal PM in a referring centre, since it is assumed that microscopic (and often macroscopic) colorectal PM are still present. The diagnostic laparoscopy/laparotomy may be performed in a referring centre, provided that the peritoneal cancer index (PCI) is appropriately scored and documented before enrolment. Patients are excluded in case of any comorbidity or condition that prevents safe administration of the planned perioperative systemic therapy, determined by the treating medical oncologist, e.g.: * Inadequate bone marrow, renal, or liver functions (e.g. haemoglobin \<6.0 mmol/L, neutrophils \<1.5 x 109/L, platelets \<100 x 109/L, serum creatinine \>1.5 x ULN, creatinine clearance \<30 ml/min, bilirubin \>2 x ULN, serum liver transaminases \>5 x ULN); * Previous intolerance of fluoropyrimidines or both oxaliplatin and irinotecan; * Dehydropyrimidine dehydrogenase deficiency; * Serious active infections; * Severe diarrhoea; * Stomatitis or ulceration in the mouth or gastrointestinal tract; * Recent major cardiovascular events; * Unstable or uncompensated respiratory or cardiac disease; * Bleeding diathesis or coagulopathy; * Pregnancy or lactation. The aforementioned laboratory values and tests are to be determined at the discretion of the physician, e.g. only if the patient is suspect for abnormal conditions tests will be conducted.
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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
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Amsterdam University Medical Centre, Location VUMC
Amsterdam, Netherlands
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Catharina Hospital
Eindhoven, Netherlands
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Erasmus University Medical Centre
Rotterdam, Netherlands
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Netherlands Cancer Institute
Amsterdam, Netherlands
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Radboud University Medical Centre
Nijmegen, Netherlands
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St. Antonius Hospital
Nieuwegein, Netherlands
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University Medical Centre Groningen
Groningen, Netherlands
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University Medical Centre Utrecht
Utrecht, Netherlands
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Ziekenhuis Oost-Limburg
Genk, Flanders, 3600, Belgium
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