NCT05673772Active, not recruitingPhase 2
Preoperative Sequential Short-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer
A Multicenter, Randomized Controlled Trial of Preoperative Sequential Short-course Radiation Therapy and Oxaliplatin-based Consolidation Chemotherapy for Locally Advanced Rectal Cancer
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 364 (estimated)
- First submitted
- 21 Dec 2022
- Start date
- 23 Oct 2020
- Primary completion date
- 28 Dec 2028
- Lead sponsor
- Kyungpook National University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT05673772
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 364
- From 23 Oct 2020 to the primary completion date, 28 Dec 2028
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Comorbidities that make it difficult to undergo chemotherapy or radiotherapy
- Currently participating in other clinical trials or receiving research medication
- Emergency Surgery
Other illness
- Colon cancer or rectal cancer located more than 10 cm from the anal verge
- Stage I rectal cancer (clinical stage cT1-2N0)
- 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)
- Peripheral sensory neuropathy with functional impairment (grade 2 or higher)
- 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
- Unhealed wounds, fractures, peptic ulcer, abscesses in the abdominal cavity
- Active gastrointestinal bleeding
- Active infections requiring antibiotics for injection
- History of hypersensitivity to the drugs in study protocol
- Patients with non-malignant tumor diseases
Lab values
- Bone marrow suppression with neutrophil count \<2 ×109/L or platelet count \<100 ×109/L prior to the first chemotherapy
- Severe renal dysfunction (GFR ≤30ml/min by Wright or Cockroft formula)
- 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
Other
- Clinically or pathologically diagnosed distant metastasis (cTanyNanyM1)
- Familial adenomatous polyposis
- Severe hepatic dysfunction
- Taking sorivudine or brivudine
- Pregnant or lactating women
- Dihydropyrimidine dehydrogenase deficiency
- Not willing to participate
Who the study is looking for
- 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
Age in the registry: 20 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gyu seog Choi Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Unknown status |
| Catholic university of Korea Incheon St. Mary's Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| jeonbuk National University Hospital Coordinator of this site? Confirm its status | Jeonju | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Gangnam Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.