New combo aims to cut rectal cancer treatment time and boost cure rates
NCT ID NCT05673772
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial tests a shorter course of radiation followed by FOLFOX chemotherapy before surgery for locally advanced rectal cancer. About 364 participants will be randomly assigned to either this new regimen or standard chemoradiation. The goal is to see if the shorter approach improves 3-year disease-free survival by targeting cancer cells early.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- short-course radiation therapy and FOLFOX chemotherapy (oxaliplatin, leucovorin, 5-FU)
- What this could lead to
- If successful, this approach could shorten preoperative treatment time and improve long-term survival for people with locally advanced rectal cancer.
- What could go wrong
- This is a mid-stage trial with 364 participants, so results are not yet proven. The experimental regimen may cause more side effects or not improve outcomes compared to standard chemoradiation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 364 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2020
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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, Korea University Anam Hospital
Seoul, South Korea
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Asan Medical Center
Seoul, 05505, South Korea
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Catholic University of Korea Incheon St. Mary's Hospital
Incheon, South Korea
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Chonnam National University Hwasun Hospital
Gwangju, South Korea
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Chungnam National University Hospital
Daejeon, South Korea
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Gangnam Severance Hospital
Seoul, South Korea
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Gyu seog Choi
Daegu, 702-210, South Korea
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Jeonbuk National University Hospital
Jeonju, South Korea
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Seoul National University Bundang Hospital
Seoul, South Korea
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Other studies related to the condition(s) this trial covers.
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- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Can two immunotherapy drugs help rectal cancer patients skip pelvic radiation?
- Can digital surveys capture the full toll of rectal cancer treatment?
- Can a targeted drug conjugate outsmart advanced colorectal cancer?
- Can a platform trial match the right drug combo to each tumor?