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Timing of chemo may boost rectal cancer remission

NCT ID NCT05054959

Disease control Sponsor: Institute of Oncology Ljubljana Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial tests whether giving chemotherapy before or after radiation therapy works better for people with locally advanced rectal cancer that has a high risk of coming back. Participants receive the same drugs (capecitabine and oxaliplatin) but in a different order. The goal is to see which sequence leads to more complete remissions, where no cancer is found after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CAPOX chemotherapy (capecitabine and oxaliplatin)
What this could lead to
If successful, this study could identify the best order of chemotherapy and radiation to increase the chance of complete tumor disappearance in high-risk rectal cancer.
What could go wrong
This is a small Phase 2 trial, so results may not apply broadly. Both chemotherapy sequences carry side effects like nerve damage, fatigue, and digestive issues.

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 62 people

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

Started

Jun 2021

Expected to finish

Dec 2028

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.

Inclusion Criteria:- histologically proven rectal adenocarcinoma * no distant metastases on CT scan (M0 disease) * at least one high risk factor for disease recurrence identified on magnetic resonance imaging (MRI): * T4 tumor (cT4) * N2 disease (cN2) * extramural venous invasion (cEMVI+) * positive lateral lymph nodes * distance of tumor to mesorectal fascia or positive lymph nodes is 1 mm or less (cMRF+) * capacity for informed consent * willingness to attend regular check-ups during and after treatment Exclusion Criteria:history of previous irradiation in the pelvic area * absolute contraindications for MR imaging * distant metastases cannot be reliably excluded * synchronous cancer * chronic inflammatory bowel disease

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

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

Locally advanced rectal cancer

Contacts and locations

Locations

  • Institute of Oncology

    Ljubljana, Slovenia, 1000, Slovenia

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