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
Pei-Rong Ding
66 participants
Dec 12, 2022
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
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Interventions
The total dosage was 25Gy consisted of 5 fractions of 5 Gy to clinical target volume without a boost dose
150 mg/m² iv drip over 2 hours on day 1, repeated every 14 days.
85 mg/m² iv drip over 2 hours on day 1, repeated every 14 days.
400 mg/m² iv drip over 2 hours on day 1, repeated every 14 days.
2400 mg/m² iv drip over 48 hours on day 1-2, repeated every 14 days.
The total dosage was 50Gy consisted of 25 fractions of 2 Gy to clinical target volume without a boost dose
825 mg/m² twice daily administered orally and concurrently with radiation therapy for 5 days per week.
Locations(1)
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NCT06417476