Short-course Radiotherapy or Long-course Chemoradiation Followed by mFOLFOXIRI Consolidation Chemotherapy for Organ Preservation in Low Rectal Cancer

Summary

Given the growing focus on preserving organ function and the utilization of neoadjuvant therapy, it is important to investigate and enhance the application of comprehensive neoadjuvant therapy in low rectal cancer. This approach aims to minimize or circumvent the organ dysfunction and subsequent decline in quality of life associated with radical surgery, with improving disease-free survival (DFS), while . Consequently, we propose to initiate a multicenter clinical trial to examine the medium- and long-term effectiveness of complete neoadjuvant therapy (comprising either short-course radiotherapy or long-course chemoradiation, followed by consolidation chemotherapy with mFOLFOXIRI) in increasing organ preservation rates in patients with low rectal cancer.

Conditions

• Rectal Neoplasms

Interventions

RADIATION

Short-course radiotherapy

The total dosage was 25Gy consisted of 5 fractions of 5 Gy to clinical target volume without a boost dose

DRUG

Irinotecan

150 mg/m² iv drip over 2 hours on day 1, repeated every 14 days.

DRUG

Oxaliplatin

85 mg/m² iv drip over 2 hours on day 1, repeated every 14 days.

DRUG

Calcium Formate

400 mg/m² iv drip over 2 hours on day 1, repeated every 14 days.

DRUG

Fluorouracil

2400 mg/m² iv drip over 48 hours on day 1-2, repeated every 14 days.

RADIATION

Long-course chemoradiation

The total dosage was 50Gy consisted of 25 fractions of 2 Gy to clinical target volume without a boost dose

DRUG

Capecitabine

825 mg/m² twice daily administered orally and concurrently with radiation therapy for 5 days per week.

Sponsors & Collaborators

• Yunnan Cancer Hospital

  collaborator OTHER

• Liaoning Cancer Hospital & Institute

  collaborator OTHER

• Shantou Central Hospital

  collaborator OTHER

• Fujian Cancer Hospital

  collaborator OTHER_GOV

• Jiangsu Provincial People's Hospital

  collaborator OTHER

• Pei-Rong Ding

  lead OTHER

Principal Investigators

• Peirong Ding, MD, Ph D · Sun Yat-sen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-12-12

Primary Completion

2025-09-30

Completion

2026-12-30

Countries

• China

Study Locations