FOLINIC ACID for Locally advanced colon adenocarcinoma (pMMR)|Colorectal cancer (stage II/III)

Stratification factors

• Tumor location (right vs left)
• Definitive pathologic stage II vs III (high risk)
• Sex
• Age

Inclusion criteria

• {"criterion_text":"-Patients of both sexes, aged ≥18 years and ≤75 years"}
• {"criterion_text":"-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"}
• {"criterion_text":"-Metastatic extension: M0"}
• {"criterion_text":"-ECOG 0-1"}
• {"criterion_text":"-Microsatellite stability (pMMR)"}
• {"criterion_text":"-Informed consent duly completed"}
• {"criterion_text":"-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\tCombined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) o\t Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) o\tIntrauterine device (IUD) o\tIntrauterine hormone-releasing system (IUS) o\tBilateral tubal occlusion o\tVasectomised partner o\tSexual abstinence"}

Exclusion criteria

• {"criterion_text":"-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"}
• {"criterion_text":"-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."}
• {"criterion_text":"-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"}
• {"criterion_text":"-Presence of un-resectability criteria in the pretreatment work-up, un-resectability will be discussed in MDT with expert oncologic surgeons."}
• {"criterion_text":"-Presence of microsatellite instability (dMMR)"}
• {"criterion_text":"-Presence of deficit of DPD."}
• {"criterion_text":"-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)"}
• {"criterion_text":"-Extraperitoneal rectal cancer (medium-low) (avoiding alterations due to neoadjuvant radiotherapy)."}
• {"criterion_text":"-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)."}
• {"criterion_text":"-Severely impaired hepatic, renal or cardiovascular function."}
• {"criterion_text":"-Contraindications to study IMPs (annex I) as per investigator criteria"}

Primary endpoints

• {"endpoint_text":"-disease-free survival (DFS; absolute DFS in months)","definition_or_measurement_approach":"Absolute DFS measured in months (disease-free survival in months)."}
• {"endpoint_text":"-Probability of DFS at 3 years (DFS 3y%)","definition_or_measurement_approach":"Probability of disease-free survival at 36 months (3-year DFS percentage)."}

Secondary endpoints

• {"endpoint_text":"-Overall survival: absolute and probability at 3 years","definition_or_measurement_approach":"Overall survival measured as absolute survival and probability at 36 months."}
• {"endpoint_text":"-Peritoneal recurrence-free survival: absolute and probability at 3 years","definition_or_measurement_approach":"Peritoneal recurrence-free survival measured as absolute time and probability at 36 months."}
• {"endpoint_text":"-Pattern of recurrence (peritoneal, hematogenous or lymphatic)","definition_or_measurement_approach":"Classification of recurrence by site/pattern (peritoneal, hematogenous, lymphatic)."}
• {"endpoint_text":"-Tumor regression grade (Dworak scale)","definition_or_measurement_approach":"Tumor regression assessed using the Dworak tumor regression scale (grade 0 to grade 5)."}
• {"endpoint_text":"-Morbidity and toxicity: Clavien Dindo classification and Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be considered.","definition_or_measurement_approach":"Morbidity assessed by Clavien Dindo classification; toxicity graded by CTCAE v5.0."}
• {"endpoint_text":"-Negative rate of ctDNA after treatment and association of detected levels with tumor recurrence and survival","definition_or_measurement_approach":"Circulating tumor DNA (ctDNA) negativity rate post-treatment and correlation analysis with recurrence and survival (ctDNA detection assays as specified in protocol)."}
• {"endpoint_text":"-Survival analysis in the following subgroups: pT4a/b, pN+, pathologic stage II/III, mutated RAS/RAF, positive/negative ctDNA","definition_or_measurement_approach":"Subgroup survival analyses stratified by pathologic stage, nodal status, RAS/RAF mutation status and ctDNA positivity/negativity."}
• {"endpoint_text":"-Tumour progression defined as per RECIST v.1.1: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).","definition_or_measurement_approach":"Tumour progression evaluated per RECIST v1.1 criteria (≥20% relative increase in sum of diameters with ≥5 mm absolute increase or appearance of new lesions)."}

Spain

Earliest CTIS Part Ii Submission Date

09-06-2025

Latest Decision Or Authorization Date

30-04-2026

Processing Time Days

325

Number Of Sites

23

Number Of Participants

1083

Primary sponsor

Full Name

Fundacion Para La Investigacion Biomedica De Cordoba

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Spanish Clinical Research Network","duties_or_roles":"sponsorDuties codes: 1,10,6","organisation_type":"Laboratory/Research/Testing facility"}