RecruitingPhase 3NCT06293625

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

Personalising and Refining Neo-adjuvant Chemotherapy in Locally Advanced but Resecable Colon Cancer in the Elderly of 70 Years Old or More Phase III Multicentric Open-label Randomized Controlled Trial

Sponsor

Centre Hospitalier Universitaire Dijon

Enrollment

150 participants

Start Date

Jun 7, 2024

Study Type

INTERVENTIONAL

Conditions

Colon Cancer

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.

Eligibility

Min Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving chemotherapy before surgery (neoadjuvant chemotherapy with FOLFOX) can improve outcomes for elderly patients (70 and older) with locally advanced colon cancer. It aims to see if pre-surgery chemo is effective and well-tolerated in this age group. **You may be eligible if...** - You are 70 years or older with biopsy-confirmed colon cancer (or upper rectal cancer too high for radiation) - Your cancer is staged as T3 or T4 with or without lymph node involvement, and has not spread to distant sites (M0) - You are fit enough for 6 weeks of FOLFOX chemotherapy followed by surgery - Your cancer is of the non-immune-active type (pMMR/MSS status) - Your blood counts and general health meet study thresholds **You may NOT be eligible if...** - You have signs of bowel obstruction - Your cancer has spread to distant sites (metastatic) - You have had prior chemotherapy for this cancer - You have significant organ or blood count problems preventing chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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