Use of neoadjuvant chemotherapy with or without HIPEC for locally advanced colon cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase III, randomized, multicenter study comparing standard treatment (surgery plus adjuvant FOLFOX) to neoadjuvant FOLFOX with or without hyperthermic intraperitoneal chemotherapy (HIPEC) followed by surgery and adjuvant therapy. Participants have locally advanced colon cancer without metastasis and are randomized equally among three groups. The primary goal is to see if the neoadjuvant approaches increase disease-free survival at 36 months. Secondary objectives include tumor regression assessment, R0 resection rate, circulating tumor DNA after surgery, and treatment-related morbidity and toxicity. The trial uses stratified randomization and will analyze outcomes by tumor location, pathologic stage, sex, and age.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario Reina Sofia
  Córdoba, Córdoba, Spain Recruiting

Study contacts

• Principal investigator: Alvaro Arjona Sánchez, MD., Ph.D. — Maimonides Biomedical Research Institute
• Study coordinator: Jose C Garrido Gracia, Ph.D
• Email: uicec@imibic.org
• Phone: +34957213831

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.