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

Sponsor
Pei-Rong Ding
Study ID
NCT06417476
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Rectal Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Short-course radiotherapy — RADIATION
    The total dosage was 25Gy consisted of 5 fractions of 5 Gy to clinical target volume without a boost dose
  • Irinotecan — DRUG
    150 mg/m² iv drip over 2 hours on day 1, repeated every 14 days.
  • Oxaliplatin — DRUG
    85 mg/m² iv drip over 2 hours on day 1, repeated every 14 days.
  • Calcium Formate — DRUG
    400 mg/m² iv drip over 2 hours on day 1, repeated every 14 days.
  • Fluorouracil — DRUG
    2400 mg/m² iv drip over 48 hours on day 1-2, repeated every 14 days.
  • Long-course chemoradiation — RADIATION
    The total dosage was 50Gy consisted of 25 fractions of 2 Gy to clinical target volume without a boost dose
  • Capecitabine — DRUG
    825 mg/m² twice daily administered orally and concurrently with radiation therapy for 5 days per week.

Study Details

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.

Key Dates

Start date
Dec 12, 2022
Status verified
Apr 2026
Primary completion
Sep 30, 2025
Completion
Dec 30, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Short-course radiotherapy followed by consolidation chemotherapy with mFOLFOXIRI
    Patients receive short-course radiotherapy (25Gy/5 times) followed by consolidation chemotherapy with mFOLFOXIRI (Irinotecan 150 mg/m2 iv gtt (2h) d1, Oxaliplatin 85 mg/m2 iv gtt (2h) d1, Calcium folinate 400 mg/m2 iv gtt (2h) d1, Total amount of fluorouracil 2400 mg/m2 iv gtt (48h)), treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. The first efficacy evaluation occurs after the fourth chemotherapy cycle. If there is no progression (a complete response (CR), partial response (PR), or stable disease (SD) with reduction or stability in tumor size) , patients will proceed with an additional four cycles. Upon the final efficacy assessment after the eighth chemotherapy cycle, patients will received several pathways (watch \& wait approach; local resection;total mesorectal excision) are considered based on the assessments.
  • Experimental: Long-course chemoradiation followed by consolidation chemotherapy with mFOLFOXIRI
    Patients receive long-course chemoradiation (50Gy/25 times;capecitabine 825 mg/m² twice daily) followed by consolidation chemotherapy with mFOLFOXIRI (Irinotecan 150 mg/m2 iv gtt (2h) d1, Oxaliplatin 85 mg/m2 iv gtt (2h) d1, Calcium folinate 400 mg/m2 iv gtt (2h) d1, Total amount of fluorouracil 2400 mg/m2 iv gtt (48h)), treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. The first efficacy evaluation occurs after the fourth chemotherapy cycle. If there is no progression (a complete response (CR), partial response (PR), or stable disease (SD) with reduction or stability in tumor size) , patients will proceed with an additional four cycles. Upon the final efficacy assessment after the eighth chemotherapy cycle, patients will received several pathways (watch \& wait approach; local resection;total mesorectal excision) are considered based on the assessments.

Primary Outcome Measure

Organ preservation rate [ Time Frame: Up to 1 years ]

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