New combo therapy aims to shrink rectal tumors before surgery
NCT ID NCT06162650
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 study tests a total neoadjuvant therapy approach for stage II or III rectal cancer. Participants receive short-course radiotherapy followed by 9 cycles of mFOLFOX6 chemotherapy before any surgery. The goal is to see how many patients achieve a complete response, meaning no cancer remains detectable. The study is recruiting 42 adults in Taiwan.
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 radiotherapy and mFOLFOX6 chemotherapy
- What this could lead to
- If successful, this approach could increase the chance of complete tumor disappearance before surgery, potentially reducing the need for more aggressive treatments.
- What could go wrong
- This is a small, early-phase study with only 42 participants, so results may not apply to all patients. Side effects from radiation and chemotherapy can be significant.
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 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Nov 2030
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 years and older
- 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: * Histologically confirmed diagnosis of adenocarcinoma of the rectum; * Tumors located at mid or low rectum (distal extension less than 10 cm from the anal verge); * Clinical stage II or III (T3/4 and/or N+; no distant metastasis); * No prior chemotherapy, radiotherapy or surgery for rectal cancer; * Age ≥20; * ECOG 0-1; * Adequate organ function, including followings: ANC ≥1,500/μL; Hb ≥8.0 gm/dL; Platelet 100,000/mm3; Total bilirubin ≤1.5x upper normal limit; AST ≤3x upper normal limit; ALT ≤3x upper normal limit; Creatinine ≤1.5x upper normal limit; * Ability to understand and the willingness to sing a written informed consent. Exclusion criteria * Recurrent rectal cancer; * Patients who have concomitant malignancies, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. Subjects who have prior malignancies and have been disease-free for more than 5 years can be enrolled; * Patients who have received prior pelvic radiotherapy; * Patients with active infection requiring intravenous antibiotic treatment; * Patients with a history of any arterial thrombotic event within the past 6 months, including unstable angina, myocardial infarction (MI) or cerebrovascular accident (CVA), New York Hear Association (NYHA) grade II or greater congestive heart failure, or uncontrolled cardiac arrhythmia; * Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgement, would make them inappropriate candidates for entry into this study; * Women who are pregnant or breastfeeding. Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period; * Patients receiving other anticancer or experimental therapy; * Known DPD deficiency or hypersensitivity to oxaliplatin; * Any contraindications to MRI.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Cheng Kung University Hospital
RECRUITINGTainan, 704, Taiwan
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