Personalising and Refining Neo-adjuvant Chemotherapy in Locally Advanced But Resecable Colon Cancer in the Elderly of 70 Years Old or More

Trial Title: Personalising and Refining Neo-adjuvant Chemotherapy in Locally Advanced But Resecable Colon Cancer in the Elderly of 70 Years Old or More

NCT ID: NCT06293625

Condition: Colon Cancer

Conditions: Official terms:
Colonic Neoplasms

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Folfox
Description: Folfox chemotherapy (folinic acid, fluorouracil and oxaliplatin) for 6 weeks (3 courses) before surgery.
Arm group label: NeoAdjuvant Chemotherapy arm

Intervention type: Procedure
Intervention name: Surgery
Description: Experimental arm: Surgery should take place 21 days after the last dose of neoadjuvant chemotherapy Control arm: upfront surgery as soon as possible
Arm group label: Current standard of care
Arm group label: NeoAdjuvant Chemotherapy arm

Summary: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Biopsy-confirmed adenocarcinoma of the colon (or upper rectum if too high for radiotherapy), high-grade dysplasia is not acceptable , - Patients with synchronous tumors are eligible, if the most advanced tumor meets the criteria above - Radiological stage T3/T4 and N0/N1/N2 and M0 - Patient eligible for curative surgery (without the necessity of chemotherapy) - No clinical, radiological and colonoscopy evidence of bowel obstruction - Age ≥ 70 at the time of registration - pMMR/MSS tumour status - Colon cancer specialist or geriatric oncologist (if available on site) assessed fit to receive 6 weeks (3 courses) of NAC with FOLFOX (either full or 80% of FOLFOX dose) and surgery - Uracilemia <16 ng/ml. - 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/LAdequate renal biochemistry: GFR >50 ml/min as assessed by local standards - Adequate hepatobiliary function: - bilirubin < 1.5 ULN (Patients with Gilbert's syndrome who have raised bilirubin but otherwise normal liver function tests are eligible for the study if bilirubin < 3 ULN) - AST/ALT < 2.5 x ULN - Patient able to understand and willing to provide written informed consent for the study - Patient affiliated to a social security scheme Exclusion Criteria: - Any patient for whom radiotherapy is advised by the MDT - Strong evidence of distant metastases or peritoneal nodules (cM1), However, cases with indeterminate abnormalities should be managed and investigated as per standard local MDT procedures and can be considered for trial entry if the MDT opinion is that these are considered most likely to be benign. - Peritonitis (secondary to perforated tumour) - T1-T2 - Serious medical comorbidity, as assessed by leading clinician (such as uncontrolled angina) - Any other malignant disease within the preceding 5 years with the exception of non-melanomatous skin cancer, carcinoma in situ and early stage disease with a recurrence risk <10% - Known dMMR/ MSI-H tumour status - Have a peripheral sensitive neuropathy with functional impairment (≥ grade 2 according to NCI-CTCAE v5.0) - Recent (within four weeks prior to randomisation) or concomitant treatment with brivudine, sorivudine or their chemically related analogues - Person under guardianship, curatorship, and safeguard of justice or person deprived of liberty - Impossible to undergo the medical follow-up of the trial for geographical, social or psychological reasons - Known hypersensitivity to the active substance of the trial treatments or to any of the excipients - Patient with poor nutritional status at appreciation by each clinician - bone marrow hypoplasia - Potentially severe infection 1 month before NAC - Patients who have received live attenuated vaccines (yellow fever, varicella, shingles, measles, mumps, rubella, tuberculosis, rotavirus, influenza) 1 month before NAC - Any case of clinically significant active heart disease or myocardial infarction within 6 months, - Any chronic condition not balanced in the last 6 months: Liver failure, renal failure, respiratory failure, - QT/QTc interval > 450 msec for men and > 470 msec for women - Known Pernicious anaemia or other anaemias due to vitamin B12 deficiency

Gender: All

Minimum age: 70 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: CHU Dijon Bourgogne

Address:
City: Dijon
Zip: 21000
Country: France

Status: Recruiting

Contact:
Last name: Côme LEPAGE
Email: come.lepage@u-bourgogne.fr

Start date: June 7, 2024

Completion date: June 2032

Lead sponsor:
Agency: Centre Hospitalier Universitaire Dijon
Agency class: Other

Source: Centre Hospitalier Universitaire Dijon

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06293625