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

NCT06293625 | Recruiting Phase 3

• 1 other identifier: LEPAGE PHRCK 2022-2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• DFS (disease Free Survival)

  3 years

Study Arms (2)

NeoAdjuvant Chemotherapy arm

EXPERIMENTAL

Drug: Folfox; Procedure: Surgery

Current standard of care

ACTIVE COMPARATOR

Procedure: Surgery

Interventions

Folfox DRUG

Folfox chemotherapy (folinic acid, fluorouracil and oxaliplatin) for 6 weeks (3 courses) before surgery.

NeoAdjuvant Chemotherapy arm

Surgery PROCEDURE

Experimental arm: Surgery should take place 21 days after the last dose of neoadjuvant chemotherapy Control arm: upfront surgery as soon as possible

Current standard of care; NeoAdjuvant Chemotherapy arm

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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 need for of chemotherapy)
• No clinical, radiological and colonoscopy evidence of bowel obstruction
• Age ≥ 70 at the time of registration
• pMMR/MSS tumour status
• Fit to receive 6 weeks (3 courses) of NAC with FOLFOX (either full or 80% of FOLFOX dose) and surgery, as assessed by a colon cancer specialist or geriatric oncologist (if available on site).
• Uracilemia \<16 ng/ml.
• 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 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
• Patient able to understand and willing to provide written informed consent for the study
• Patient affiliated to a social security scheme

You may not qualify if:

• 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
• Impossibility 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 within1 month before NAC

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21000, France

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Folfox protocol; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Côme LEPAGE

CONTACT

come.lepage@u-bourgogne.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 5, 2024
• Study Start: June 7, 2024
• Primary Completion (Estimated): June 1, 2032
• Study Completion (Estimated): June 1, 2032
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)