Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New combo therapy aims to shrink rectal tumors before surgery

NCT ID NCT06162650

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Nov 2030

An estimate. End dates often move.

Lead sponsor

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

20 years and older

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Rectal adenocarcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 704, Taiwan

More trials for these conditions

Other studies related to the condition(s) this trial covers.