Actively Recruiting
Personalising and Refining Neo-adjuvant Chemotherapy in Locally Advanced but Resecable Colon Cancer in the Elderly of 70 Years Old or More
Led by Centre Hospitalier Universitaire Dijon · Updated on 2025-03-30
150
Participants Needed
1
Research Sites
416 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Personalising and Refining Neo-adjuvant Chemotherapy in Locally Advanced but Resecable Colon Cancer in the Elderly of 70 Years Old or More
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-confirmed adenocarcinoma of the colon or upper rectum if too high for radiotherapy
- Patients with synchronous tumors eligible if the most advanced tumor meets criteria
- Radiological stage T3/T4 and N0/N1/N2 and M0
- Eligible for curative surgery without need for chemotherapy
- No evidence of bowel obstruction clinically, radiologically, or by colonoscopy
- Age 70 years or older at registration
- pMMR/MSS tumour status
- Fit to receive 6 weeks of neoadjuvant Folfox chemotherapy and surgery, as assessed by specialist
- Uracilemia less than 16 ng/ml
- Adequate blood counts: WBC >3.0 x10^9/L; platelets >100 x10^9/L; neutrophils ≥1.5 x10^9/L
- Anemia corrected before surgery and chemotherapy; surgery and chemotherapy allowed if anemia persists per clinical decision
- Serum electrolytes within specified limits: Ca >2.1 mmol/L, Mg >0.65 mmol/L, K >3.4 mmol/L
- Adequate renal function with GFR >50 ml/min
- Adequate liver function: bilirubin <1.5 x ULN (or <3 x ULN for Gilbert's syndrome), AST/ALT <2.5 x ULN
- Able and willing to provide written informed consent
- Affiliated to a social security scheme
You will not qualify if you...
- Radiotherapy advised by the multidisciplinary team
- Strong evidence of distant metastases or peritoneal nodules (cM1)
- Peritonitis due to perforated tumour
- Tumor stage T1-T2
- Serious medical comorbidity such as uncontrolled angina
- Other malignant disease within past 5 years except certain low-risk cancers
- Known dMMR/MSI-H tumour status
- Peripheral sensitive neuropathy with functional impairment grade ≥2
- Recent or current treatment with brivudine, sorivudine, or related drugs
- Under guardianship, curatorship, or deprived of liberty
- Unable to follow medical trial procedures due to geographic, social, or psychological reasons
- Known hypersensitivity to trial treatments or excipients
- Poor nutritional status
- Bone marrow hypoplasia
- Severe infection within 1 month prior to chemotherapy
- Live attenuated vaccines within 1 month before chemotherapy
- Active significant heart disease or myocardial infarction within 6 months
- Uncontrolled chronic conditions in last 6 months like liver, renal, or respiratory failure
- QT/QTc interval >450 msec for men, >470 msec for women
- Known pernicious anemia or vitamin B12 deficiency anemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU Dijon Bourgogne
Dijon, France, 21000
Actively Recruiting
Research Team
C
Côme LEPAGE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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