Heated chemo wash may stop colorectal cancer spreading in abdomen
NCT ID NCT01226394
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tested whether a surgical procedure called laparotomy plus heated chemotherapy (HIPEC) could improve outcomes for colorectal cancer patients at high risk of cancer spreading in the abdomen. 150 patients who had already undergone surgery and chemotherapy were randomly assigned to either standard follow-up or the additional surgery with HIPEC. The goal was to see if the extra treatment could increase the time patients lived without the cancer returning.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hyperthermic intraperitoneal chemotherapy (HIPEC)
- What this could lead to
- If successful, this could provide a way to prevent or delay the return of cancer in the abdomen for high-risk colorectal patients.
- What could go wrong
- This is a completed phase 3 trial, but results are not yet widely confirmed. The procedure is invasive and carries risks like infection or organ damage.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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150 people
The number who actually took part.
- Started
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Jun 2010
- Finished
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Jan 2021
- 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 to 70 years
- 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.
Inclusion Criteria: A) Patients presenting with the following history: 1. Histologically-proven colorectal adenocarcinoma 2. Presenting at the time of resection of the primary with one of the following 4 criteria (criteria indicating a high risk of developing PC) : * Minimal PC, resected at the same time as the primary * Ovarian metastases * Rupture of the primary tumour inside the peritoneal cavity, * Iatrogenic rupture of the primary tumour during surgery B) Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) : * Chemotherapy with the Folfox 4 regimen (the current standard treatment ; it can be modified in the future in the two groups, if the standard is modified…). * Given on an intent-to-treat basis (it can be stopped prematurely for miscellaneous reasons…); C) Patients who do not present any sign of tumour recurrence at the end of these 6 months of chemotherapy. D) Patients with the following general characteristics: 1. Age between 18 and 70 years, 2. Performance Status WHO \< 2, life expectancy \> 12 weeks, 3. Haematological parameters : Polynuclear neutrophils ³ 1.5x109/L, platelets ³ 100x109/L, 4. Liver function : Total Bilirubin £ 1.5 x ULN, AST (SGOT) et ALT (SGPT) £ 3 x ULN, alkaline phosphatases £ 3 x ULN, 5. Renal function : Plasma creatinine £ 1,25 x ULN, 6. Operable patients, 7. Grade £ 2 peripheral neuropathy (CTC AE v3.0 annex 7) 8. Patients entitled to French National Health Insurance coverage. E)Patients will be informed and a signed consent form will be obtained before initiating any procedure specific to the trial. Exclusion Criteria: 1. Cancers of non colorectal origin, particularly, appendiceal cancers are excluded 2. Patients presenting with a detectable recurrent tumour 3. Grade ≥ 3 Peripheral neuropathy 4. History of cancer (excepted cutaneous basocellullar cancer or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years 5. Patients already included in another trial concerning first-line treatment 6) Pregnant women or likely to be pregnant 7\) Persons under guardianship 8) Follow-up impossible for geographic, social or psychological reasons
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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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Institut Gustave Roussy
Villejuif, 94800, France
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Other studies related to the condition(s) this trial covers.
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