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Efficacy of the Use of Neoadjuvant With/Without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer

RecruitingPhase 3Ages 18 Years - 75 YearsAllMaimónides Biomedical Research Institute of Córdo…
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In plain words

What the trial is, and whether it could suit you

The main objective of this randomized and controlled trial is to determine whether the use of a proactive strategy, systemic neoadjuvant treatment (FOLFOX) with or without hyperthermic intraperitoneal chemoterapy (HIPEC) with mitomycin C followed by postoperative systemic adjuvant treatment, increases disease-free survival at 36 months in patients with locally advanced colon cancer compared to standard treatment. Therefore, a phase III, randomized, academic, multicenter, controlled trial will be conducted. Patients with locally advanced colon adenocarcinoma (cT4, cT3 with invasion \>5mm) Nx and no metastases will be included. Control group (n=361) will receive standard treatment (surgery and adjuvant chemotherapy FOLFOX x 12 based); Experimental group 1 (n=361) = Neoadjuvant chemotherapy (FOLFOX x6) + surgery (associating HIPEC) and FOLFOX x 6; Experimental group 2 (n=361): Neoadjuvant c

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📋 Eligibility rules (as published)
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.
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What it tests

  • Mitomycin (MM)
  • FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
  • Cytoreductive surgery
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Where

1 site
Hospital Universitario Reina Sofia
Córdoba, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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