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Rectal cancer breakthrough: could a new drug combo save your rectum?

NCT ID NCT06758830

Disease control Sponsor: National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether a combination of chemotherapy and radiation (total neoadjuvant therapy, or TNT) can shrink rectal tumors enough so that some patients can avoid surgery and instead be monitored closely. About 400 adults with early-stage rectal cancer will be randomly assigned to receive TNT followed by a watch-and-wait approach, or to have surgery first. The goal is to see if the non-surgical approach leads to similar survival and quality of life, while preserving the rectum.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 400 people

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

Started

Jan 2025

Expected to finish

Dec 2029

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

18 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.

Part One Inclusion Criteria: * Over 18 years of age. * Participants who agreed to participate in the study signed an informed consent form. * The Eastern Cooperative Oncology Group (ECOG) score ranges from 0 to 2. * Pathologically confirmed rectal adenocarcinoma. * Tumor up to 10 cm from the anus. * Magnetic resonance imaging (MRI) of the pelvis and computed tomography (CT) of the thorax and abdomen were performed to confirm the diagnosis. * cT1N1, T2-T3 N0 - 1, M0, MRF -, EMVI -. * Normal bone marrow function: blood leucocytes \> 3.5 × 10⁹/l, neutrophils \> 1.5 × 10⁹/l, platelets \> 100 × 10⁹/l. * Normal renal function: creatinine within 1,5 × normal. * Normal liver function: blood bilirubin levels within 1,5 times normal, AST, ALT levels within 2,5 times the upper limit. Exclusion Criteria: * Prior ST or Ch. * Participants who are not eligible for pelvic MRI. * Participants who have had a malignancy in the last 5 years, except for treatment for basal cell or squamous cell skin cancer or in situ cervical cancer. * ECOG status ≥ 3. * Distant metastases detected. * Participants with uncontrolled therapeutic or psychiatric conditions. * Infectious diseases requiring antibiotic treatment. Part Two Inclusion Criteria: * Over 18 years of age. * Participants who agreed to participate in the study signed an informed consent form. * ECOG score between 0 and 2. * Pathological confirmed rectal adenocarcinoma. * Stage I to III rectal cancer confirmed. * The tumor is localized up to 12 cm from the anus. * Participants who refused to participate in the first part of the study or did not meet the inclusion criteria for the first part. * Participants have received preoperative CRT or TNT or are in the planning stages of neoadjuvant treatment. Exclusion Criteria: * New cancer two years after CRT. * Stage IV cancer before treatment. * Participants refusing to participate in the study or unable to sign the informed consent.

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Conditions

The condition(s) this trial relates to.

chemotherapy-induced toxicity Fatigue Low Anterior Resection Syndrome Postoperative Complications radiation injury rectal cancer rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chemoradiotherapy Chemotherapy Chemotherapy side effects Low anterior resection syndrome Neoadjuvant therapy Organ preservation Quality of life Radiotherapy Radiotherapy side effect Rectal cancer Total neoadjuvant treatment

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

  • Nacional Cancer Institute

    RECRUITING

    Vilnius, 08660, Lithuania

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