Heated chemo during surgery could boost colon cancer survival
NCT ID NCT06783491
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 3 trial is testing whether giving chemotherapy before surgery, with or without a heated chemotherapy wash inside the abdomen during surgery, can help people with locally advanced colon cancer live longer without the cancer returning. About 1,083 participants will be randomly assigned to standard treatment or one of two experimental groups. The study aims to see if these proactive approaches improve disease-free survival at 3 years compared to current care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FOLFOX (combination chemotherapy) and mitomycin C (given as heated intraperitoneal chemotherapy during surgery)
- What this could lead to
- If successful, this could offer a more effective treatment strategy for locally advanced colon cancer, potentially reducing the chance of cancer coming back after surgery.
- What could go wrong
- This is a large phase 3 trial, but results are not yet known. The added treatments may cause more side effects, and it's unclear if the benefits will outweigh the risks for all patients.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 1,083 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2026
- Expected to finish
-
Dec 2030
An estimate. End dates often move.
- 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 75 years
- Sex
-
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 of both sexes, aged ≥18 years and ≤75 years (patients between 70-75 years old will be discussed in committee). * Adenocarcinoma of the colon, sigmoid colon and rectum-sigmoid junction that is cT4a/b according to the American Joint Committee on Cancer (AJCC) TNM eight edition. Pre-treatment diagnosis by imaging test (CT scan or MRI). High-risk cT3 with invasion into surrounding fat greater than 5mm may be included. * Nodal extension: cN0, the presence of cN1/2 according to AJCC TNM 8th edition is allowed as long as they can be resected. Pre-treatment diagnosis by imaging test (CT scan or MRI). * Metastatic extension: cM0. Patients with cM1 are not allowed to be included. * ECOG 0-1. * Microsatellite stability (pMMR). * Informed consent duty completed. Exclusion Criteria: * Presence of metastases (M1). If liver or peritoneal metastases are present at the time of surgery, the patient will be excluded from the study and treated according to the new stage. * Presence of un-resectability criteria in the pretreatment work-up, un-resectability will be discussed in MDT with expert oncologic surgeons. * Presence of microsatellite instability (dMMR). * Presence of deficit of DPD. * Urgent intervention due to obstruction or perforation if the primary tumour is removed. Bridge interventions such as transit shunts without removal of the primary tumour or percutaneous drainage of collections prior to neoadjuvant treatment or scheduled surgery will be accepted. * Extraperitoneal rectal cancer (medium-low) (avoiding alterations due to neoadjuvant radiotherapy). * Coexistence of another relevant malignant neoplastic disease (synchronous colon and rectum-sigmoid tumours are accepted as long as the stage is equal or lower than the treated tumour), it will be discussed in steering committee. * Severely impaired hepatic, renal or cardiovascular function. * Intolerance to treatment. * Gestational or lactating women.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Locally advanced colon adenocarcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Hospital Universitario Reina Sofia
RECRUITINGCórdoba, Córdoba, 14004, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can immunotherapy plus chemo melt colorectal tumors before surgery?
- Can an antimalarial drug boost immunotherapy against colorectal cancer?
- Triple therapy aims to wipe out colorectal cancer before surgery
- New personalized vaccine takes on tough cancers
- Personalized Pre-Surgery cocktails aim to wipe out colorectal cancer
- New drug combo aims to outsmart tough colorectal cancer