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Active, not recruiting Phase 2

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

NCT05673772 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 2
Started
2020-10-23
Last updated
2026-02-12

Condition(s) studied

Rectal Cancer

Investigational drug(s) / intervention(s)

short-course radiotherapymFOLFOX6 →ChemoradiotherapyTME surgery

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

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

Sex
ALL
Min age
20 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Asian * ECOG (Eastern Cooperative Oncology Group) performance status 0-2 * Pathologically confirmed rectal cancer (rectal cancer located 10 cm or low from the anal 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 on pelvis MRI: cTanyN1-2, cT3-4N0, or presence of extramural vascular invasion * MRI findings such as pelvic lymph node metastasis, anal sphincter invasion, and T4b are not included in the exclusion criteria, which cases will be enrolled by the researcher's discretion * Patients with appropriate organ (bone marrow, kidney, liver) function * A person who understands the study and willing to provide informed consent 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 for cured 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 or glucose-galactose malabsorption * Taking tegafur, gimeracil, and oteracil potassium complex and those within 7 days of discontinuation * 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

Primary outcome measure(s)

  • 3-year disease-free survival — 3 years
    To compare the 3-year disease-free survival between the experimental arm and the control arm

Trial sites (9)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05673772 on ClinicalTrials.gov ↗ ← All trials in South Korea