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

Last updated: February 10, 2026
Sponsor: Kyungpook National University Hospital
Overall Status: Active - Not Recruiting

Phase

2

Condition

Digestive System Neoplasms

Colon Cancer

Rectal Cancer

Treatment

mFOLFOX6

TME surgery

short-course radiotherapy

Clinical Study ID

NCT05673772
KNUHCRC007
  • Ages 20-75
  • All Genders

Study 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.

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

Total Participants: 364
Treatment Group(s): 4
Primary Treatment: mFOLFOX6
Phase: 2
Study Start date:
October 23, 2020
Estimated Completion Date:
December 28, 2031

Connect with a study center

  • Gyu seog Choi

    Daegu, 702-210
    Korea, Republic of

    Site Not Available

  • Chungnam National University Hospital

    Daejeon,
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Gwangju,
    Korea, Republic of

    Site Not Available

  • Catholic University of Korea Incheon St. Mary's Hospital

    Incheon,
    Korea, Republic of

    Site Not Available

  • Jeonbuk National University Hospital

    Jeonju,
    Korea, Republic of

    Site Not Available

  • , Korea University Anam Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Gangnam Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Gyu seog Choi

    Daegu 1835329, 702-210
    South Korea

    Site Not Available

  • Chungnam National University Hospital

    Daejeon 1835235,
    South Korea

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Gwangju 1841811,
    South Korea

    Site Not Available

  • Catholic University of Korea Incheon St. Mary's Hospital

    Incheon 1843564,
    South Korea

    Site Not Available

  • Jeonbuk National University Hospital

    Jeonju 1845457,
    South Korea

    Site Not Available

  • , Korea University Anam Hospital

    Seoul 1835848,
    South Korea

    Site Not Available

  • Asan Medical Center

    Seoul 1835848, 05505
    South Korea

    Site Not Available

  • Gangnam Severance Hospital

    Seoul 1835848,
    South Korea

    Site Not Available

  • Seoul National University Bundang Hospital

    Seoul 1835848,
    South Korea

    Site Not Available

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