RecruitingPhase 3NCT05201430

Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer

Neoadjuvant FOLFOXIRI Chemotherapy Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer: An Open Label Randomized Controlled Phase III Trial

Sponsor

Fudan University

Enrollment

300 participants

Start Date

Aug 27, 2021

Study Type

INTERVENTIONAL

Conditions

Rectal Cancer

Summary

This is a phase III randomized controlled trial comparing the efficacy and safety of FOLFOXIRI versus CapeOX as neoadjuvant regimen in treating patients with middle and upper locally advanced (MRI T3-4 or N+) rectal cancer. This study aims to optimize the neoadjuvant therapy for patients with anus-preserving resectable locally advanced rectal cancer, so as to improve the prognosis of them. It remains unclear about whether FOLFOXIRI or CapeOX neoadjuvant chemotherapy is more effective for locally advanced rectal cancer.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy regimens — FOLFOXIRI (three drugs) versus CapeOX (two drugs) — given before surgery in patients with locally advanced rectal cancer, to find out which leads to better outcomes. **You may be eligible if...** - You are between 18 and 75 years old - You have rectal cancer confirmed by biopsy (adenocarcinoma type) - Your cancer is locally advanced (T3–T4 or node positive) based on MRI - The tumor is in the rectum (within 15 cm of the anus) and surgery is planned - You have not received prior chemotherapy, radiation, or local excision for this cancer - Your blood counts, liver, and kidney function are within acceptable limits **You may NOT be eligible if...** - You have a second cancer (except early skin cancer) - Your cancer has spread to other organs - You have received prior treatment for this rectal cancer - Your organ function is too impaired for 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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Interventions

DRUGFOLFOXIRI

irinotecan\* 165 mg/m² iv continue for 1.5 hours, D1 oxaliplatin 85 mg/m² iv continue for 2 hours, D1 leucovorin 400 mg/m² iv continue for 2 hours, D1 5-FU 2400\~3200 mg/m² cont. inf. 48h, D1 repeat every 2 weeks (Q2W)

DRUGCapeOX

oxaliplatin 130 mg/m2 iv continue for 2 hours, D1 capecitabine 1000mg/m2/d PO Bid, once every morning and evening D1-14 repeat every 3 weeks (Q3W)

Locations(1)

Department of Colorectal Surgery Fudan University Shanghai Caner Center

Shanghai, Shanghai Municipality, China

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NCT05201430

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