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Can a shorter radiation course spare the rectum in rectal cancer?

NCT ID NCT04246684

Cure Sponsor: Prof. Dr. med. Claus Rödel 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This phase 3 trial tests two different ways of using radiation before chemotherapy in people with stage III rectal cancer. One group gets a short course of radiation, the other gets standard chemoradiation, both followed by chemotherapy. The goal is to see if either approach can shrink the tumor enough that some patients can avoid surgery entirely and keep their rectum, a strategy called watch-and-wait. The study focuses on patients with intermediate or high-risk features seen on MRI, and it will compare how often the rectum can be preserved while keeping the cancer from coming back.

What this could mean

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

Active substance
Radiotherapy (short-course or chemoradiotherapy) followed by chemotherapy, with possible watch-and-wait instead of surgery
What this could lead to
If successful, this approach could allow more people with rectal cancer to keep their rectum and avoid major surgery, while maintaining good cancer control.
What could go wrong
The trial is large but still experimental. Not everyone will respond completely, and some may still need surgery or face side effects from the intense treatment.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

702 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Sep 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: * diagnosis of rectal adenocarcinoma localised 0 - 12 cm from the anocutaneous line as measured by rigid rectoscopy (i.e. lower and middle third of the rectum) * Staging requirements: High-resolution, thin-sliced (i.e. 3mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure. * MRI-defined inclusion criteria: presence of at least one of the following high-risk conditions: * any cT3 if the distal extent of the tumor is \< 6 cm from the anocutaneous line, or * cT3c/d in the middle third of the rectum (≥ 6-12 cm) with MRI evidence of extramural tumor spread into the mesorectal fat of more than 5 mm (\>cT3b), or * cT3 with clear cN+ based on strict MRI-criteria * cT4 tumors, or * Tany middle/low third of rectum with clear MRI criteria for N+ * mrCRM+ (\< 1mm), or * Extramural venous invasion (EMVI+) * Trans-rectal endoscopic ultrasound (EUS) is additionally used when MRI is not definitive to exclude early cT1/T2 disease in the lower third of the rectum or early cT3a/b tumors in the middle third of the rectum. * Spiral-CT of the abdomen and chest to exclude distant metastases. * Aged at least 18 years. No upper age limit. * WHO/ECOG Performance Status 0-1 * Adequate haematological, hepatic, renal and metabolic function parameters: * Leukocytes ≥ 3.000/mm\^3, ANC ≥ 1.500/mm\^3, platelets ≥ 100.000/mm\^3, Hb \> 9 g/dl * Serum creatinine ≤ 1.5 x upper limit of normal * Bilirubin ≤ 2.0 mg/dl, SGOT-SGPT, and AP ≤ 3 x upper limit of normal • Informed consent of the patient Exclusion Criteria: * Lower border of the tumor localised more than 12 cm from the anocutaneous line as measured by rigid rectoscopy * Distant metastases (to be excluded by CT scan of the thorax and abdomen) * Prior antineoplastic therapy for rectal cancer * Prior radiotherapy of the pelvic region * Major surgery within the last 4 weeks prior to inclusion * Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. * Subject (male or female) is not willing to use highly effective methods of Contraception during treatment and for 6 months after the end of treatment. * On-treatment participation in a clinical study in the period 30 days prior to inclusion * Previous or current drug abuse * Other concomitant antineoplastic therapy * Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active, uncontrolled infections, active, disseminated coagulation disorder * Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) \< 6 months before enrolment * Prior or concurrent malignancy \< 3 years prior to enrolment in study (Exception: non-melanoma Skin cancer or cervical carcinoma FIGO stage 0-1), if the patient is continuously disease-free * Known allergic reactions on study medication * Known dihydropyrimidine dehydrogenase deficiency * Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (these conditions should be discussed with the patient before registration in the trial).

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Conditions

The condition(s) this trial relates to.

rectal carcinoma rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

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

Rectal cancer stage III

Contacts and locations

Locations

  • "St. Bernward" Clincal Center Hildesheim

    Hildesheim, Lower Saxony, 31134, Germany

  • Alexianer Krefeld GmbH / Maria Hilf Krankenhaus

    Krefeld, 47805, Germany

  • Brother clinic St. Josef, Paderborn

    Paderborn, North Rhine-Westphalia, 33098, Germany

  • CaritasClinic Saarbrücken

    Saarbrücken, Saarland, 66113, Germany

  • Clincal Center "Bogenhausen" Munich

    München, Bavaria, 81925, Germany

  • Clincal Center "St. Marien" Amberg

    Amberg, Bavaria, 92224, Germany

  • Clincal Center Chemnitz

    Chemnitz, Saxony, 09113, Germany

  • Clincal Center Darmstadt

    Darmstadt, Hesse, 64283, Germany

  • Clincal Center Esslingen

    Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany

  • Clincal Center Helios Bad Saarrow

    Bad Saarow, Brandenburg, 15526, Germany

  • Clincal Center Helios Berlin Buch

    Berlin, State of Berlin, 13125, Germany

  • Clinic Bayreuth GmbH

    Bayreuth, Bavaria, 95445, Germany

  • Clinic Fulda

    Fulda, Hesse, 36043, Germany

  • Clinic Lippe GmbH (Lemgo/Detmold)

    Detmold, North Rhine-Westphalia, 32756, Germany

  • Clinic Maria Hilf GmbH

    Mönchengladbach, North Rhine-Westphalia, 41063, Germany

  • Clinic Nordoberpfalz AG, Clinic Weiden

    Weiden, Bavaria, 92637, Germany

  • Clinic North West gGmbH Frankfurt

    Frankfurt am Main, Hesse, 60488, Germany

  • Clinic Ostlab, Staufenclinic Schwaeb.Gmuend, Mutlangen

    Mutlangen, Baden-Wurttemberg, 73557, Germany

  • Clinic Sankt Georg gGmbH, Leipzig

    Leipzig, Saxony, 04129, Germany

  • Clinic Stuttgart

    Stuttgart, Baden-Wurttemberg, 70174, Germany

  • Clinic Wolfsburg

    Wolfsburg, Lower Saxony, 38440, Germany

  • Clinical Center "Essen Mitte"

    Essen, North Rhine-Westphalia, 45136, Germany

  • Clinical Center "Mutterhaus" Trier

    Trier, Rhineland-Palatinate, 54290, Germany

  • Clinical Center Coburg

    Coburg, Bavaria, 96450, Germany

  • DRK Clincal Centers North Hessen Kassel

    Kassel, Hesse, 34121, Germany

  • Department of Radiooncology

    Frankfurt, Frankfurt, 60590, Germany

  • Dietrich Bonhoeffer Klinik

    Neubrandenburg, 17036, Germany

  • Ev. Waldkrankenhaus, Spandau,

    Berlin, State of Berlin, 13589, Germany

  • Evangelical Clinic Wesel

    Wesel, North Rhine-Westphalia, 46485, Germany

  • Helios Klinikum Berlin Emil von Behring

    Berlin, State of Berlin, 14650, Germany

  • Hematological-Oncological Practice Dr. Oleg Rubanov, Hameln

    Hamelin, Lower Saxony, 31785, Germany

  • Hospital "Barmherzige Brüder" Regensburg

    Regensburg, Bavaria, 93046, Germany

  • Hospital Bochum

    Bochum, North Rhine-Westphalia, 44892, Germany

  • Klinikum Bielefeld

    Bielefeld, 33604, Germany

  • Klinikverbund Allgäu

    Kempten (Allgäu), Bavaria, 87439, Germany

  • Lahn-Dill Clinics Wetzlar

    Wetzlar, Hesse, 35578, Germany

  • MVZ Oncological Cooperation Harz

    Goslar, Lower Saxony, 38642, Germany

  • Mathias-Spital, Rheine

    Rheine, North Rhine-Westphalia, 48431, Germany

  • Med. Statistik Saarbrücken GgR

    Saarbrücken, Saarbruecken, 66113, Germany

  • Medical Project Hannover

    Hanover, Lower Saxony, 30171, Germany

  • Medius Clincal Center Ostfildern-Ruit

    Ostfildern, Baden-Wurttemberg, 73760, Germany

  • Oncology Practice Dresden

    Dresden, Saxony, 01307, Germany

  • Oncology UnterEms, Leer

    Leer, Lower Saxony, 26789, Germany

  • Oncology in Medicinum Hildesheim

    Hildesheim, Lower Saxony, 31135, Germany

  • Onkologische Schwerpunktpraxis

    Darmstadt, 64287, Germany

  • Pi.Tri-Studien GmbH, Offenburg

    Offenburg, Baden-Wurttemberg, 77654, Germany

  • Pius Hospital, Oldenburg

    Oldenburg, Lower Saxony, 25121, Germany

  • Praxis für Hämatologie und Onkologie

    Giessen, 35392, Germany

  • Prosper Hospital Recklinghausen

    Recklinghausen, North Rhine-Westphalia, 45659, Germany

  • Radiotherapy Practice Dr. A. Schreiber, Dresden

    Dresden, Saxony, 01067, Germany

  • Sana Clinical Center Offenbach

    Offenbach, Hesse, 63069, Germany

  • Schwarzwald-Baar-Kliniken

    Villingen-Schwenningen, Villingen-Schwenningen, 78052, Germany

  • St. Josef Hospital of the catholic clinic Bochum

    Bochum, North Rhine-Westphalia, 44791, Germany

  • St. Vincenz Hospital Paderborn

    Paderborn, North Rhine-Westphalia, 33098, Germany

  • Technical University Clinic Munich

    München, Bavaria, 81675, Germany

  • Technical University Munich

    München, Bavaria, 81675, Germany

  • Uniklinik Schleswig Holstein

    Lübeck, 23538, Germany

  • University Clinic Erlangen

    Erlangen, Bavaria, 91054, Germany

  • University Clinic Essen

    Essen, North Rhine-Westphalia, 45122, Germany

  • University Clinic Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • University Clinic Göttingen

    Göttingen, Lower Saxony, 37075, Germany

  • University Clinic Kiel

    Kiel, Schleswig-Holstein, 24105, Germany

  • University Clinic Leipzig

    Leipzig, Saxony, 04103, Germany

  • University Clinic Magdeburg

    Magdeburg, Saxony-Anhalt, 39120, Germany

  • University Clinic Mainz

    Mainz, Rhineland-Palantine, 55116, Germany

  • University Clinic Mannheim

    Mannheim, Baden-Wurttemberg, 68167, Germany

  • University Clinic Marburg

    Marburg, Hesse, 35043, Germany

  • University Clinic Oldenburg

    Oldenburg, Lower Saxony, 26133, Germany

  • University Clinic Regensburg

    Regensburg, Bavaria, 93053, Germany

  • University Clinic Rostock

    Rostock, Mecklenburg-Vorpommern, 18059, Germany

  • University Clinic Ulm

    Ulm, Baden-Wurttemberg, 89081, Germany

  • University Clinic Würzburg

    Würzburg, Bavaria, 97080, Germany

  • University Clinic for Radioncology Tübingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitätsklinikum Halle

    Halle, 06120, Germany

  • Vivantes Clincial Center in Friedrichshain

    Berlin, State of Berlin, 10249, Germany

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