MRI-Guided radiation boosts hopes for rectal cancer patients

NCT ID NCT04815694

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This trial investigates whether adjusting radiation doses based on early tumor shrinkage seen on daily MRI scans can improve outcomes for people with locally advanced rectal cancer. Participants receive standard chemoradiation, but those whose tumors shrink slowly get a higher radiation dose to the remaining tumor. The study also collects blood and stool samples to build better prediction models. The main goal is to see if this personalized approach leads to more complete tumor disappearances.

What this could mean

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

Active substance
Radiation dose escalation (up to 60.1 Gy) guided by MRI and early tumor regression index
What this could lead to
If successful, this approach could increase the number of patients who achieve a complete response, potentially avoiding surgery and improving survival.
What could go wrong
This is a single-center, non-randomized study, so results may not apply broadly. Dose escalation also carries a risk of increased side effects to nearby organs.

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 179 people

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

Started

Mar 2021

Expected to finish

Oct 2031

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: * Histological proven adenocarcinoma of the rectum; * cT2-4, or cN0-2 (also extramesorectal nodes), or mesorectal fascia involvement for tumor (MRF+) or extramural venous invasion (EMVI+); * cM0; * No prior radiotherapy in pelvic region; * Tumour located between 0 and 15 cm above the anal verge; * Not mesorectal fascia involvement for tumor; * No extramesorectal nodes involvement; * No extramural venous invasion (EMVI); * No rectal mucinous adenocarcinoma histology; * No contra-indications for MRI; * ECOG 0-1; * Age over 18 years; * Adequate hematological function: granulocyte count \> 1500/microl, Hemoglobin level \> 10 g/dl, Platelet count \> 100000/microl, ALT/AST: 7-45 UI/L; * No other malignancies in the previous history (except skin and initial cervical cancer); * Absence of important comorbidities: severe cardiac or coagulative disease, moderate or severe restrictive/obstructive lung deficit, severe cognitive impairment, moderate and severe renal and hepatic impairment; * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial; * Absence of pregnancy or lactating female patients; * Written informed consent. Exclusion Criteria: * Distant metastases (cM1); * Prior radiotherapy in the pelvic region; * Tumour located lower than 0 cm or higher than 15 cm above the anal verge; * Rectal mucinous adenocarcinoma histology; * Contra-indications for Magnetic Resonance Imaging (MRI); * Eastern Cooperative Oncology Group (ECOG) performance status score \>= 2; * Age under 18 years; * Inadequate hematological function (Granulocyte count \<= 1500/microl, Hemoglobin level \<= 10 g/dl, Platelet count \<= 100000/microl, ALT/AST outside 7-45 UI/L); * History of other malignancies (except skin cancer and initial cervical cancer); * Presence of severe comorbidities (severe cardiac or coagulative disease, moderate or severe restrictive/obstructive lung deficit, severe cognitive impairment, moderate/severe renal or hepatic impairment); * Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; * Pregnant or lactating female patients.

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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.

  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

  • Fondazione Policlinico Universitario A.Gemelli IRCCS

    RECRUITING

    Roma, Roma, 00168, Italy

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