OncoMatch/Clinical Trials/NCT06293625
Personalising and Refining Neo-adjuvant Chemotherapy in Locally Advanced but Resecable Colon Cancer in the Elderly of 70 Years Old or More
Is NCT06293625 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Folfox for colon cancer.
Treatment: Folfox — Colon cancer (CC) is the 5th most common cancer worldwide. Standard care for locally advanced disease is surgical resection followed by 3-6 months of adjuvant chemotherapy (AC) with oxaliplatin and 5-fluorouracil (OxFp). Almost all of these patients undergo surgery, but many do not receive AC due to frailty (following surgery). This particularly affects patients over 70, who represent the majority of patients diagnosed with CC. FOxTROT 2, a trial to test the role of NAC in older patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MMR proficient
pMMR/MSS tumour status
Excluded: MMR deficient
Known dMMR/MSI-H tumour status
Disease stage
Excluded: Stage CM1
Radiological stage T3/T4 and N0/N1/N2 and M0
Prior therapy
Cannot have received: brivudine or sorivudine or chemically related analogues (brivudine, sorivudine)
Recent (within four weeks prior to randomisation) or concomitant treatment with brivudine, sorivudine or their chemically related analogues
Cannot have received: live attenuated vaccine (yellow fever, varicella, shingles, measles, mumps, rubella, tuberculosis, rotavirus, influenza)
Patients who have received live attenuated vaccines (yellow fever, varicella, shingles, measles, mumps, rubella, tuberculosis, rotavirus, influenza) within 1 month before NAC
Lab requirements
Blood counts
WBC >3.0 x10^9/l; platelets >100 x10^9/l; neutrophils ≥ 1.5 x10^9/l; anaemia (Hb < 10.0 g/dl) not exclusion if corrected by transfusion
Kidney function
GFR >50 ml/min as assessed by local standards
Liver function
bilirubin < 1.5 x ULN (Gilbert's syndrome: < 3 x ULN); AST/ALT < 2.5 x ULN
Cardiac function
QT/QTc interval > 450 msec for men and > 470 msec for women [excluded]
Adequate full blood count: WBC >3.0 x109/l; platelets >100 x109/l and neutrophils ≥ 1.5 x x109/l Anaemia (Hb < 10.0 g/dl) is not an exclusion, but should be corrected by transfusion prior to surgery and chemotherapy. If Hb remains low despite transfusions, surgery and chemotherapy can be given according to the decision of the surgical and oncology teams. Serum electrolytes: Ca2+ > 2.1 mmol/L, Mg2+ > 0.65 mmol/L, K+> 3.4 mmol/L Adequate renal biochemistry: GFR >50 ml/min as assessed by local standards Adequate hepatobiliary function: * bilirubin < 1.5 x ULN (Patients with Gilbert's syndrome who have raised bilirubin but otherwise normal liver function tests are eligible for the study if bilirubin < 3 x ULN) * AST/ALT < 2.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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