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Efficacy of the use of neoadjuvant with/without hyperthermic intraperitoneal chemotherapy in the treatment of locally advanced colon cancer
EU CTIS ID: 2025-520471-29-00
What this study is testing
To determine whether the use of proactive systemic neoadjuvant treatment (FOLFOX) with or without HIPEC with mitomycin C followed by post-surgical systemic adjuvant treatment increases disease-free survival at 36 months in patients with locally advanced colon cancer compared to standard treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients of both sexes, aged ≥18 years and ≤75 years
- Adenocarcinoma of the colon, sigmoid colon and rectum-sigmoid junction that is cT4a/b according to the American Joint Committee on Cancer (AJCC) TNM eigth 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
- Metastatic extension: M0
- ECOG 0-1
- Microsatellite stability (pMMR)
- Informed consent duly completed
You likely can't join if
- 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
- Intolerance to treatment. Hypersensitivity to Mitomycin C, Fluoropyrimidine or oxaliplatin. This means individuals with a history of allergic or other adverse reactions to a these specific drugs or their related substances are excluded from participating.
- Gestational or lactating women. If female and of childbearing potential, must: - Have a negative pregnancy test ≤72hours prior to initiating study treatment - Agree to avoid pregnancy during and for 6 months after study treatment
- 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.
See the full eligibility criteria
- Patients of both sexes, aged ≥18 years and ≤75 years
- Adenocarcinoma of the colon, sigmoid colon and rectum-sigmoid junction that is cT4a/b according to the American Joint Committee on Cancer (AJCC) TNM eigth 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
- Metastatic extension: M0
- ECOG 0-1
- Microsatellite stability (pMMR)
- Informed consent duly completed
- Subjects must agree to utilize a highly effective* method of contraception during heterosexual intercourse from the screening visit throughout the duration of the study (*) Highly effective methods of contraception as defined by the Clinical Trial Facilitation Group (CTFG) (“Recommendations related to contraception and pregnancy testing in clinical trials”, version 15/09/2014) o Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) o Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) o Intrauterine device (IUD) o Intrauterine hormone-releasing system (IUS) o Bilateral tubal occlusion o Vasectomised partner o Sexual abstinence
- 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
- Intolerance to treatment. Hypersensitivity to Mitomycin C, Fluoropyrimidine or oxaliplatin. This means individuals with a history of allergic or other adverse reactions to a these specific drugs or their related substances are excluded from participating.
- Gestational or lactating women. If female and of childbearing potential, must: - Have a negative pregnancy test ≤72hours prior to initiating study treatment - Agree to avoid pregnancy during and for 6 months after study treatment
- 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.
- Coexistence of another malignant neoplastic disease (synchronous colon and rectum-sigmoid tumors are accepted as long as the stage is equal or lower than the treated tumor)
- Extraperitoneal rectal cancer (medium-low) (avoiding alterations due to neoadjuvant radiotherapy).
- Coexistence of another malignant neoplastic disease (synchronous colon and rectum-sigmoid tumors are accepted as long as the stage is equal or lower than the treated tumor).
- Severely impaired hepatic, renal or cardiovascular function.
- Contraindications to study IMPs (annex I) as per investigator criteria
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.