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New study aims to find best rectal cancer treatment for seniors

NCT ID NCT06052332

Disease control Sponsor: Jules Bordet Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Updated 2 times

Summary

This study compares two standard treatment approaches for older adults (age 70+) with locally advanced rectal cancer. The goal is to see which approach helps people live longer and with fewer side effects. About 230 participants will be randomly assigned to receive either conventional therapy or total neoadjuvant therapy before surgery.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 230 people

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

Started

Feb 2024

Expected to finish

Dec 2033

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

70 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: 1. Age ≥ 70 years old 2. ECOG performance status (PS): * ≤1 if age \> 75 years old * ≤2 if age ≤ 75 years old 3. Histologically or cytologically confirmed adenocarcinoma of the rectum 4. Distal border of the tumour below the peritoneal reflection and within 15 cm of the anal verge 5. Operable stage III or high-risk stage II rectal cancer (high-risk tumours defined as those having ≥1 of the following features: T4, mesorectal fascia (MRF) involvement/threatening \[i.e.,tumour within 1 mm of the MRF\], extramural venous invasion). Patient with involvement of lateral pelvic lymph nodes are also eligible. 6. Adequate bone marrow function as defined below: * Absolute neutrophil count ≥1,500/µL * Haemoglobin ≥9 g/dL * Platelets ≥100,000/µL 7. Adequate liver function as defined below: * Serum total bilirubin ≤1.5 x ULN. In case of known Gilbert's syndrome \<3xUNL is allowed * AST (SGOT) and ALT (SGPT) ≤2.5 x ULN * Alkaline phosphatase ≤2.5 x ULN 8. Adequate renal function as defined by estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73m² (according to the CKD-EPI 2021 equation). 9. Absence of clinical conditions that in the opinion of the investigator, would contraindicate neoadjuvant therapy and/or surgery. 10. Signed Informed Consent form (ICF) obtained prior to any study related procedure. 11. Male subjects with partners of childbearing potential must agree to use condom during the course of this study and for at least 6 months after the last administration of study drugs. Exclusion Criteria: 1. Extensive growth into cranial part of the sacrum (above S2/3 junction) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumour down-sizing is achieved. 2. Presence of metastatic disease or recurrent rectal tumour. 3. Presence of grade ≥2 peripheral neuropathy according to the Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0. 4. Significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study. 5. Any contraindication to pelvic irradiation as evaluated by the investigator. 6. Known hypersensitivity reactions to the study drugs or to any excipients, premedications or non-investigational medicinal products or concomitant medications. 7. Any investigational anti-cancer therapy other than the protocol specified therapies (participation in other prospective studies which do not imply any specific intervention may be allowed after discussion with the Study Chair). 8. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment. 9. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure (grade III or IV as classified by the New York Heart Association), or serious cardiac arrhythmia requiring medication within the past 6 months. 10. Complete dihydropyrimidine dehydrogenase (DPD) deficiency. 11. Any previous treatment for rectal cancer. 12. Use of brivudine, sorivudine or their chemically related analogues.

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm

As listed by the trial registrant

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

Locally advanced rectal cancer Older people

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    19 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • AZ Nikolaas

    RECRUITING

    Sint-Niklaas, East Flanders, 9100, Belgium

  • AZ Turnhout

    RECRUITING

    Turnhout, Antwerpen, 2300, Belgium

  • CHA Libramont

    RECRUITING

    Libramont, Luxemburg, 6800, Belgium

  • CHR Sambre et Meuse (site Meuse)

    NOT_YET_RECRUITING

    Namur, Namur, 5000, Belgium

  • CHU Ambroise Pare

    NOT_YET_RECRUITING

    Mons, Hainaut, 7000, Belgium

  • CHU Brugmann

    RECRUITING

    Brussels, Brussels Capital, 1020, Belgium

  • CHU Charleroi

    NOT_YET_RECRUITING

    Charleroi, Namur, 6042, Belgium

  • CHU Saint-Pierre

    RECRUITING

    Brussels, Brussels Capital, 1000, Belgium

  • CHU St Elisabeth

    RECRUITING

    Namur, Namur, 5000, Belgium

  • CHU UCL Namur

    RECRUITING

    Godinne, Namur, 5530, Belgium

  • CHU de Liège - Sart Tilman

    RECRUITING

    Liège, Liège, 4000, Belgium

  • Chirec Delta

    RECRUITING

    Auderghem, Brussels Capital, 1160, Belgium

  • Epicura

    RECRUITING

    Hornu, Hainaut, 7301, Belgium

  • Grand Hôpital De Charleroi

    SUSPENDED

    Charleroi, Namur, 6000, Belgium

  • Hôpital de Jolimont

    RECRUITING

    Haine-Saint-Paul, Hainaut, 7100, Belgium

  • Institut Jules Bordet

    RECRUITING

    Anderlecht, Brussels Capital, 1070, Belgium

  • UZ Gent

    RECRUITING

    Ghent, East Flanders, 9000, Belgium

  • UZA Antwerpen

    RECRUITING

    Edegem, Antwerpen, 2650, Belgium

    Contact Email: •••••@•••••

  • ZAS Antwerpen

    RECRUITING

    Antwerp, Antwerpen, 2610, Belgium

More trials for these conditions

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