RecruitingPhase 2NCT06417476

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

A Multicenter, Open, Randomized, Phase II Trial:Short-course Radiotherapy or Long-course Chemoradiation Followed by MFOLFOXIRI Consolidation Chemotherapy for Organ Preservation in Low Rectal Cancer


Sponsor

Pei-Rong Ding

Enrollment

66 participants

Start Date

Dec 12, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different approaches to treating rectal cancer — short-course radiation followed by intensive chemotherapy versus long-course chemoradiation followed by the same chemotherapy — with the goal of preserving the rectum and avoiding the need for a permanent colostomy bag. **You may be eligible if...** - You are 18–70 years old - You have been diagnosed with rectal cancer confirmed by biopsy (adenocarcinoma) - Your cancer is at an early to moderately advanced stage (cT2–4a, N0–2) - The lower edge of your tumor is within 8 cm of the anus - You have not had prior surgery, chemotherapy, or radiotherapy for your rectal cancer - Your cancer is pMMR-positive (a specific marker checked by biopsy) - Your general health is good (ECOG 0 or 1) and your blood counts and organ function are acceptable **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body - Your tumor has a specific genetic marker (dMMR/MSI-H — your doctor can check this) - You have previously received treatment for rectal cancer - You have another active cancer - You are pregnant or breastfeeding 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

RADIATIONShort-course radiotherapy

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

DRUGIrinotecan

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

DRUGOxaliplatin

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

DRUGCalcium Formate

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

DRUGFluorouracil

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

RADIATIONLong-course chemoradiation

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

DRUGCapecitabine

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


Locations(1)

651 Dongfeng Road East

Guangzhou, Guangdong, China

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NCT06417476


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