A Phase 3 interventional study of Mitomycin (MM) and FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) in Locally Advanced Colorectal Cancer, sponsored by Maimónides Biomedical Research Institute of Córdoba. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Maimónides Biomedical Research Institute of Córdoba · Phase 3, Interventional, and Treatment
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 chemotherapy (FOLFOX x6) + surgery and FOLFOX x 6. Randomization will be 1:1:1, stratified and centralized. The primary outcome will be disease-free survival at 36 months. Secondary outcomes will be tumor regression rate, ctDNA negativization, peritoneal relapse rate at 36 months, pattern of relapse, toxicity, morbidity and overall survival. Considering the results obtained with these two independent strategies (FOLFOX and HIPEC), a new trial is justified in order to provide strong evidence for this proactive treatment. The aim is to combine both to obtain a better benefit, which opens the direct possibility of increasing the current percentage of disease-free survival. The results of this study will have important scientific and social impact, since is aimed at improving the outcomes of one subpopulation of patients with locally advanced colon cancer whose current treatment, is not enough to avoid the recurrence of disease.
he MAIN HYPOTHESIS of this trial is that the combination of systemic neoadjuvant chemotherapy with hyperthermic intraperitoneal chemotherapy (HIPEC) will have a synergistic effect in preventing disease recurrence (at all levels) in patients with locally advanced colorectal cancer.
Therefore, the GENERAL OBJECTIVE of this study is 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. To achieve this general goal, we will implement the following specific objectives (SO):
SO1: To determine the efficacy of neoadjuvant systemic treatment with or without HIPEC association disease-free survival (DFS) at 36 months.
SO2: To conduct a stratified analysis by factors including tumor location (right/left), definitive pathologic stage II/III (high risk), sex and age.
SO3: To evaluate tumor regression after neoadjuvant treatment using the Dworak tumor regression scale (grade 0-no regression to grade 5-total response).
SO4: To evaluate the R0 surgery rate in the different treatment groups.
SO5: To compare the circulating tumor DNA (ctDNA) detected after surgery in both, experimental and control groups and analyze its impact in survival according to its detection.
SO6: To evaluate the morbidity and toxicity in the different treatment groups.
SO7: To determine the efficacy of neoadjuvant systemic treatment with or without HIPEC association in peritoneal (local or diffuse) recurrence-free survival (PFS) at 36 months.
SO8: To evaluate the effect of neoadjuvant therapy associated with HIPEC compared to neoadjuvant treatment on the pattern of disease recurrence.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 1,083 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Maimónides Biomedical Research Institute of Córdoba is the lead sponsor of 79 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FOLFOX x6 (12 weeks) followed by cytoreductive surgery + HIPEC (mitomycin 30mg/m2 for 60 min) followed by FOLFOX x6 (12 weeks).
Drug: Mitomycin (MM) · Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) · Procedure: Cytoreductive surgery
FOLFOX x6 (12 weeks) followed by cytoreductive surgery followed by FOLFOX x6 (12 weeks).
Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) · Procedure: Cytoreductive surgery
cytoreductive surgery followed by standard care (adjuvant therapy according to local protocol). Cytoreductive surgery will be defined as complete tumour resection including oncologic colectomy and adjacent structures with suspicious of infiltration to achieve a R0, bilateral oophorectomy is recommended in post-menopausal women.
Procedure: Cytoreductive surgery
Mitomycin 30mg/m2/4 litres of perfusion liquid (dextrose 1.5%). Single intraoperative dose.
FOLFOX6 consists in oxaliplatin 85 mg/m2 iv. on day 1, 5FU 400 mg/m2 iv. in bolus followed by 2400 mg/m2 in a continuous infusion for 46 hours. Leucovorin: 400mg/m2 folinic acid (racemid dl) in a continuous infusion for 2 hours. Repeat every 2 weeks. Haematological recovery to ANC \>1.5x109/L and platelets \>75x109/L should be ensured prior to Day 1 of each 14-day cycle.
Cytoreductive surgery will be defined as complete tumour resection including oncologic colectomy and adjacent structures with suspicious of infiltration to achieve a R0, bilateral oophorectomy is recommended in post-menopausal women
Disease-free survival absolute
Absolute disease-free survival in months. The event will be defined by patient death from any cause or tumour recurrence
Time frame: 36 months after treatment.
Disease-free survival probability
Tumour disease-free survival at 3 years of follow-up (%). The event will be defined by patient death from any cause or tumour recurrence up to 36 months after treatment.
Time frame: 36 months after treatment.
Absolute Overall survival
The event will be defined by patient death from any cause
Time frame: 36 months after treatment.
Probability overall survival
Probability of survival at 3 years. The event will be defined by patient death from any cause up to 36 months after treatment
Time frame: 36 months after treatment.
Tumour regression
Tumour regression grade (Dworak's scale)
Time frame: 12 weeks after treatment
ctDNA rate
Negative rate of ctDNA after treatment and association of detected levels with tumour recurrence and survival.
Time frame: 36 months after treatment.
Absolute Disease-free survival in subgroups
Absolute disease-free survival in months in the following subgroups: pT4a/b/pT3b, pN+, pathologic stage II/III, right/left colon cancer mutated RAS/RAF, positive/negative ctDNA. The event will be defined by patient death from any cause or tumour recurrence
Time frame: 36 months after treatment.
Disease-free survival probability in subgroups
Tumour disease-free survival at 3 years of follow-up (%) in the following subgroups: pT4a/b/pT3b, pN+, pathologic stage II/III, right/left colon cancer mutated RAS/RAF, positive/negative ctDNA. The event will be defined by patient death from any cause or tumour recurrence
Time frame: 36 months after treatment.
Plan to share: Undecided
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Started May 2026 (actual). Primary completion is estimated for Jun 2030, 48 months after the start.
Of 106 non-industry phase 3 interventional studies under Colorectal Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 116. This study's planned 48 months is below that.
Counting every sponsor, half of 175 studies reached it within 50 months; a quarter within 35 and three quarters within 79.
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Studies of the drugs tested here: Mitomycin · Folfox protocol
Maimónides Biomedical Research Institute of Córdoba