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Preoperative Sequential Short-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer
Sponsor: Kyungpook National University Hospital
Summary
The treatment protocol proposed in this study is to perform short-term radiation therapy and 4 cycles of FOLFOX chemotherapy for neoadjuvant treatment of locally advanced rectal cancer. Compared to conventional chemoradiation therapy, the preoperative radiotherapy period is shortened, and the cure rate of rectal cancer patients can be improved by early treatment of micrometastasis using systemic chemotherapy. The patients who are assigned to the study group will received the short-course radiotherapy and 4 cycles of FOLFOX and patients in the control will received conventional chemoradiotherapy for preoperative treatment. All patients are recommended to receive total mesorectal excision (TME) after neoadjuvant treatment and adjuvant chemotherapy will be given according to the pathological stage.
Official title: A Multicenter, Randomized Controlled Trial of Preoperative Sequential Short-course Radiation Therapy and Oxaliplatin-based Consolidation Chemotherapy for Locally Advanced Rectal Cancer
Key Details
Gender
All
Age Range
20 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
364
Start Date
2020-10-23
Completion Date
2031-12-28
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
short-course radiotherapy
25 Gy in 5 fractions for 5 days
mFOLFOX6
Oxaliplatin 85 mg/m2, Levoleucovorin 200mg (or Leucovroin, Leucosodium 400mg)/m2, 5- FU 400 mg/m2, and continuous 5- FU 2,400 mg/m2 for 46 hours
Chemoradiotherapy
45\~50.4 Gy/25fr with concurrent use of either capecitabine or 5-FU+leucovorin(or levoleucovorin or leucosodium)
TME surgery
TME surgery
Locations (9)
Gyu seog Choi
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Chonnam National University Hwasun Hospital
Gwangju, South Korea
Catholic University of Korea Incheon St. Mary's Hospital
Incheon, South Korea
Jeonbuk National University Hospital
Jeonju, South Korea
Asan Medical Center
Seoul, South Korea
, Korea University Anam Hospital
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Seoul National University Bundang Hospital
Seoul, South Korea