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ACTIVE NOT RECRUITING
NCT05673772
PHASE2

Preoperative Sequential Short-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer

Sponsor: Kyungpook National University Hospital

View on ClinicalTrials.gov

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

RADIATION

short-course radiotherapy

25 Gy in 5 fractions for 5 days

DRUG

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

RADIATION

Chemoradiotherapy

45\~50.4 Gy/25fr with concurrent use of either capecitabine or 5-FU+leucovorin(or levoleucovorin or leucosodium)

PROCEDURE

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