Phase
Condition
Digestive System Neoplasms
Colon Cancer
Rectal Cancer
Treatment
mFOLFOX6
TME surgery
short-course radiotherapy
Clinical Study ID
Ages 20-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Asian
ECOG (Eastern Cooperative Oncology Group) performance status 0-2
Pathologically confirmed rectal cancer (rectal cancer located 10 cm or low from theanal verge in pelvis MRI)
Histologic type: adenocarcinoma, mucinous carcinoma, and signet ring cell carcinoma
Locally advanced rectal cancer with one or more of the following factors based onpelvis MRI: cTanyN1-2, cT3-4N0, or presence of extramural vascular invasion
MRI findings such as pelvic lymph node metastasis, anal sphincter invasion, and T4bare not included in the exclusion criteria, which cases will be enrolled by theresearcher's discretion
Patients with appropriate organ (bone marrow, kidney, liver) function
A person who understands the study and willing to provide informed consent
Exclusion
Exclusion Criteria: (one of the following criteria)
Colon cancer or rectal cancer located more than 10 cm from the anal verge
Stage I rectal cancer (clinical stage cT1-2N0)
Clinically or pathologically diagnosed distant metastasis (cTanyNanyM1)
Familial adenomatous polyposis
Hereditary nonpolyposis colorectal cancer
History of chemotherapy or radiotherapy within 6 months
History of colorectal cancer or other type of malignancy within 5 years (except forcured nonmelanoma skin or in situ cervical cancer)
Comorbidities that make it difficult to undergo chemotherapy or radiotherapy
Bone marrow suppression with neutrophil count <2 ×109/L or platelet count <100 ×109/L prior to the first chemotherapy
Peripheral sensory neuropathy with functional impairment (grade 2 or higher)
Severe renal dysfunction (GFR ≤30ml/min by Wright or Cockroft formula)
Severe hepatic dysfunction
Genetic problems such as galactose intolerance, Lapp lactase deficiency orglucose-galactose malabsorption
Taking tegafur, gimeracil, and oteracil potassium complex and those within 7 days ofdiscontinuation
Taking sorivudine or brivudine
Significant heart disease or myocardial infarction within the last 6 months
Hereditary diseases or history of coagulopathy
Central nervous system disorders with disability or mental disorders
Pregnant or lactating women
Currently participating in other clinical trials or receiving research medication
Unhealed wounds, fractures, peptic ulcer, abscesses in the abdominal cavity
Active gastrointestinal bleeding
Active infections requiring antibiotics for injection
Emergency Surgery
History of hypersensitivity to the drugs in study protocol
Patients with non-malignant tumor diseases
Dihydropyrimidine dehydrogenase deficiency
Not willing to participate
Study Design
Connect with a study center
Gyu seog Choi
Daegu, 702-210
Korea, Republic ofSite Not Available
Chungnam National University Hospital
Daejeon,
Korea, Republic ofSite Not Available
Chonnam National University Hwasun Hospital
Gwangju,
Korea, Republic ofSite Not Available
Catholic University of Korea Incheon St. Mary's Hospital
Incheon,
Korea, Republic ofSite Not Available
Jeonbuk National University Hospital
Jeonju,
Korea, Republic ofSite Not Available
, Korea University Anam Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Gangnam Severance Hospital
Seoul,
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Gyu seog Choi
Daegu 1835329, 702-210
South KoreaSite Not Available
Chungnam National University Hospital
Daejeon 1835235,
South KoreaSite Not Available
Chonnam National University Hwasun Hospital
Gwangju 1841811,
South KoreaSite Not Available
Catholic University of Korea Incheon St. Mary's Hospital
Incheon 1843564,
South KoreaSite Not Available
Jeonbuk National University Hospital
Jeonju 1845457,
South KoreaSite Not Available
, Korea University Anam Hospital
Seoul 1835848,
South KoreaSite Not Available
Asan Medical Center
Seoul 1835848, 05505
South KoreaSite Not Available
Gangnam Severance Hospital
Seoul 1835848,
South KoreaSite Not Available
Seoul National University Bundang Hospital
Seoul 1835848,
South KoreaSite Not Available

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