AzTrials
AzTrials

Rectal Cancer Stage IIIPhase 3NCT04246684

Short RT Versus RCT,Followed by Chemo and Organ Preservation for Interm and High-risk Rectal Cancer Patients

A Phase 3 study testing Oxaliplatin, 85 mg/m2, 5FU; 2400 mg/m2 and 5FU, 250 mg/m2 in people with Rectal Cancer Stage III, run by Prof. Dr. med. Claus Rödel at 75 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The hereby proposed ACO/ARO/AIO-18.1 randomized trial aims to directly compare the newly established TNT concepts applying either short-course RT according to RAPIDO, or CRT according to CAO/ARO/AIO-04/-12, both followed by consolidation chemotherapy, and surgery or a watch\&wait (W\&W) approach for patients with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer Stage III
What is being tested?
Oxaliplatin, 85 mg/m2, 5FU; 2400 mg/m2 and 5FU, 250 mg/m2
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
702 participants
Where
75 sitesGermany
Study dates
5 Nov 2020to 15 Sep 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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

Who cannot join

  • 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.
Show all 16Show fewer
  • 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).

Trial locations and contacts

75 sites in 1 country.

75 sites in 1 country

Germany75 sites

  • Clincal Center "St. Marien" Amberg

    Amberg, Bavaria, 92224

  • Clincal Center Helios Bad Saarrow

    Bad Saarow, Brandenburg, 15526

  • Clinic Bayreuth GmbH

    Bayreuth, Bavaria, 95445

  • Vivantes Clincial Center in Friedrichshain

    Berlin, State of Berlin, 10249

  • Clincal Center Helios Berlin Buch

    Berlin, State of Berlin, 13125

  • Ev. Waldkrankenhaus, Spandau,

    Berlin, State of Berlin, 13589

  • Helios Klinikum Berlin Emil von Behring

    Berlin, State of Berlin, 14650

  • Klinikum Bielefeld

    Bielefeld, 33604

  • St. Josef Hospital of the catholic clinic Bochum

    Bochum, North Rhine-Westphalia, 44791

  • Hospital Bochum

    Bochum, North Rhine-Westphalia, 44892

  • Clincal Center Chemnitz

    Chemnitz, Saxony, 09113

  • Clinical Center Coburg

    Coburg, Bavaria, 96450

  • Clincal Center Darmstadt

    Darmstadt, Hesse, 64283

  • Onkologische Schwerpunktpraxis

    Darmstadt, 64287

  • Clinic Lippe GmbH (Lemgo/Detmold)

    Detmold, North Rhine-Westphalia, 32756

  • Radiotherapy Practice Dr. A. Schreiber, Dresden

    Dresden, Saxony, 01067

  • Oncology Practice Dresden

    Dresden, Saxony, 01307

  • University Clinic Erlangen

    Erlangen, Bavaria, 91054

  • University Clinic Essen

    Essen, North Rhine-Westphalia, 45122

  • Clinical Center "Essen Mitte"

    Essen, North Rhine-Westphalia, 45136

  • Clincal Center Esslingen

    Esslingen am Neckar, Baden-Wurttemberg, 73730

  • Department of Radiooncology

    Frankfurt, Frankfurt, 60590

  • Clinic North West gGmbH Frankfurt

    Frankfurt am Main, Hesse, 60488

  • University Clinic Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Clinic Fulda

    Fulda, Hesse, 36043

  • Praxis für Hämatologie und Onkologie

    Giessen, 35392

  • MVZ Oncological Cooperation Harz

    Goslar, Lower Saxony, 38642

  • University Clinic Göttingen

    Göttingen, Lower Saxony, 37075

  • Universitätsklinikum Halle

    Halle, 06120

  • Hematological-Oncological Practice Dr. Oleg Rubanov, Hameln

    Hamelin, Lower Saxony, 31785

  • Medical Project Hannover

    Hanover, Lower Saxony, 30171

  • "St. Bernward" Clincal Center Hildesheim

    Hildesheim, Lower Saxony, 31134

  • Oncology in Medicinum Hildesheim

    Hildesheim, Lower Saxony, 31135

  • DRK Clincal Centers North Hessen Kassel

    Kassel, Hesse, 34121

  • Klinikverbund Allgäu

    Kempten (Allgäu), Bavaria, 87439

  • University Clinic Kiel

    Kiel, Schleswig-Holstein, 24105

  • Alexianer Krefeld GmbH / Maria Hilf Krankenhaus

    Krefeld, 47805

  • Oncology UnterEms, Leer

    Leer, Lower Saxony, 26789

  • University Clinic Leipzig

    Leipzig, Saxony, 04103

  • Clinic Sankt Georg gGmbH, Leipzig

    Leipzig, Saxony, 04129

  • Uniklinik Schleswig Holstein

    Lübeck, 23538

  • University Clinic Magdeburg

    Magdeburg, Saxony-Anhalt, 39120

  • University Clinic Mainz

    Mainz, Rhineland-Palantine, 55116

  • University Clinic Mannheim

    Mannheim, Baden-Wurttemberg, 68167

  • University Clinic Marburg

    Marburg, Hesse, 35043

  • Clinic Maria Hilf GmbH

    Mönchengladbach, North Rhine-Westphalia, 41063

  • Technical University Clinic Munich

    München, Bavaria, 81675

  • Technical University Munich

    München, Bavaria, 81675

  • Clincal Center "Bogenhausen" Munich

    München, Bavaria, 81925

  • Clinic Ostlab, Staufenclinic Schwaeb.Gmuend, Mutlangen

    Mutlangen, Baden-Wurttemberg, 73557

  • Dietrich Bonhoeffer Klinik

    Neubrandenburg, 17036

  • Sana Clinical Center Offenbach

    Offenbach, Hesse, 63069

  • Pi.Tri-Studien GmbH, Offenburg

    Offenburg, Baden-Wurttemberg, 77654

  • Pius Hospital, Oldenburg

    Oldenburg, Lower Saxony, 25121

  • University Clinic Oldenburg

    Oldenburg, Lower Saxony, 26133

  • Medius Clincal Center Ostfildern-Ruit

    Ostfildern, Baden-Wurttemberg, 73760

  • Brother clinic St. Josef, Paderborn

    Paderborn, North Rhine-Westphalia, 33098

  • St. Vincenz Hospital Paderborn

    Paderborn, North Rhine-Westphalia, 33098

  • Prosper Hospital Recklinghausen

    Recklinghausen, North Rhine-Westphalia, 45659

  • Hospital "Barmherzige Brüder" Regensburg

    Regensburg, Bavaria, 93046

  • University Clinic Regensburg

    Regensburg, Bavaria, 93053

  • Mathias-Spital, Rheine

    Rheine, North Rhine-Westphalia, 48431

  • University Clinic Rostock

    Rostock, Mecklenburg-Vorpommern, 18059

  • Med. Statistik Saarbrücken GgR

    Saarbrücken, Saarbruecken, 66113

  • CaritasClinic Saarbrücken

    Saarbrücken, Saarland, 66113

  • Clinic Stuttgart

    Stuttgart, Baden-Wurttemberg, 70174

  • Clinical Center "Mutterhaus" Trier

    Trier, Rhineland-Palatinate, 54290

  • University Clinic for Radioncology Tübingen

    Tübingen, Baden-Wurttemberg, 72076

  • University Clinic Ulm

    Ulm, Baden-Wurttemberg, 89081

  • Schwarzwald-Baar-Kliniken

    Villingen-Schwenningen, Villingen-Schwenningen, 78052

  • Clinic Nordoberpfalz AG, Clinic Weiden

    Weiden, Bavaria, 92637

  • Evangelical Clinic Wesel

    Wesel, North Rhine-Westphalia, 46485

  • Lahn-Dill Clinics Wetzlar

    Wetzlar, Hesse, 35578

  • Clinic Wolfsburg

    Wolfsburg, Lower Saxony, 38440

  • University Clinic Würzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

About this study

Official title: Short-course Radiotherapy Versus Chemoradiotherapy, Followed by Consolidation Chemotherapy, and Selective Organ Preservation for MRI-defined Intermediate and High-risk Rectal Cancer Patients

The hereby proposed ACO/ARO/AIO-18.1 randomized trial aims to directly compare the newly established TNT concepts applying either short-course RT according to RAPIDO, or CRT according to CAO/ARO/AIO-04/-12, both followed by consolidation chemotherapy, and surgery or a watch\&wait (W\&W) approach for patients with clinical complete response (cCR).

The ACO/ARO/AIO-18.1 study incorporates several novel and innovative aspects to further optimize multimodal rectal cancer treatment, partly established by our preceding CAO/ARO/AIO-04 and CAO/ARO/AIO-12 randomized trials: (1) patient selection is based on strict, quality controlled MRI features of intermediate and high-risk characteristics (and, thus, complementary to our ACO/ARO/AIO-18.2 trial in "low-risk" rectal cancer), (2) the CRT regimens incorporates 5-FU/oxaliplatin with doses and intensities shown to be effective and well-tolerated without compromising treatment compliance in CAO/ARO/AIO-04, (3) the sequence of CRT, CT, and surgery/W\&W adopts the TNT approach as established by our CAO/ARO/AIO-12 and OPRA trial, (4) surgical stratification allows for W\&W management for strictly selected patients with clinical complete response (cCR). Thus, we hypothesize that TNT with 5-FU/oxaliplatin-CRT followed by consolidation chemotherapy may increase organ preservation while maintaining DFS as compared to RAPIDO-like short-course RT followed by consolidation chemotherapy.

Read the detailed description

The primary endpoint of this trial, organ preservation, is defined as follows: survival with rectum intact, no major surgery, no stoma. Accordingly, the primary endpoint, organ preservation, will not be reached if any of the following occurs: (1) death, (2) any major surgery other than local excision (R0) performed after randomization, during TNT, at re-staging scheduled 22-24 weeks after start of TNT due to clinical non-cCR, or for any locoregional regrowth after initial cCR requiring salvage-TME, (3) any locoregional regrowth not amenable to salvage surgery, or (4) any stoma (non-re-converted protective stoma within 6 months after completion of TNT, or any stoma needed for toxicity or poor function), whichever occurs first. We hypothesized that the 3-year organ preservation rate will improve from 30% in the control arm to 40% in the investigational arm (hazard ratio of 0.76). With a power of 90% and a two-sided type I error of 5%, the sample size required to obtain a statistically significant difference is 702 patients (564 events) in total.

Being tested
Oxaliplatin, 85 mg/m2, 5FU; 2400 mg/m2, 5FU, 250 mg/m2, 5FU, 2400 mg/m2, Oxaliplatin 50 mg/m2
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxaliplatin, 85 mg/m2Drug

    Also called Control arm

    85 mg/m2,2h-civ, day 22, 36, 50, 64, 78, 92, 106, 120, and 134 of therapy

  • 5FU; 2400 mg/m2Drug

    Also called 5-FU, control arm

    2400 mg/m2, 46h-civ, day 22, 36, 50, 64, 78, 92, 106, 120, 134 of therapy for Control arm

  • 5FU, 250 mg/m2Drug

    Also called Experimental arm: 5-FU

    250 mg/m2 per day, civ, on day 1-14, day 22-35 of radiotherapy;

  • 5FU, 2400 mg/m2Drug

    Also called experimental arm

    2400 mg/m2,46h-civ, d64, d78, d92, d106, d120, d134 of therapy

  • Oxaliplatin 50 mg/m2Drug

    Also called Experimental arm

    50 mg/m2, 2h-civ, d1, d8, d21, d29 of radiotherapy and

  • Folinic Acid, 400 mg/m2Drug

    Also called Folinic Acid

    2h-civ day 22, 36, 50, 64, 78, 92, 106, 120, and 134 of therapyfor Control arm; 400 mg/m2, 2h-civ d 64, d78, d92, d106, d120, d134 of therapy for experimental arm

  • Radiotherapy control, 5x5 Gy: 25 GyRadiation

    Control arm: 5x5 Gy (total: 25 Gy) 5 fractions

  • Capecitabine, 1000 mg/m2Drug

    Also called Capecitabine

    1000 mg/m2 (twice daily) day1-14 every three weeks instead of 5FU optional

  • Oxaliplatin 85 mg/m2Drug

    Also called experimental arm

    85 mg/m2, 2h-civ, d64, d78, d92, d106, d120, d134 of therapy

  • radiotherapy experimental, 30 x 1,8 Gy: 54 GyRadiation

    30 x 1.8 Gy (total: 54 Gy), 5 fractions per week

  • Capecitabine, 825 mg/m2Drug

    Also called Capecitabine

    825 mg/m2 bid, per os, on day 1-14, 22-35 of RT instead of 5FU optional

  • Oxaliplatin, 130 mg/m2Drug

    Also called Oxaliplatin

    day1every three weeks (optional)

Study groups in NCT04246684
Study groupRoleWhat they receive
Control armActive comparatorIn the control arm patients receive 5x5 Gy followed by 9 cycles of consolidation chemotherapy mFOLFOX6 or alternatively 6 cycles of CAPOX, followed by re-staging at week 22-24 as established as new preferred neoadjuvant regimen by the RAPIDO trial.
Receives: Drug: Oxaliplatin, 85 mg/m2; Drug: 5FU; 2400 mg/m2; Drug: Folinic Acid, 400 mg/m2; Radiation: Radiotherapy control, 5x5 Gy: 25 Gy; Drug: Capecitabine, 1000 mg/m2; Drug: Oxaliplatin, 130 mg/m2
Experimental armExperimentalThe experimental arm starts with Fluoropyrimidin/Oxaliplatin-based CRT (1.8 Gy to 45 Gy to the primary tumor and pelvic lymph nodes; followed by sequential boost of 9 Gy to the gross tumor volume) followed by consolidation chemotherapy with 6 cycles mFOLFOX6 or alternatively 4 cycles CAPOX, followed by re-staging at week 22-24. In both arms, for patients achieving a clinical complete response (cCR), as strictly assessed by clinical investigation, endoscopy and MRI, a W\&W option with close follow-up is scheduled. In case of non-complete response, immediate TME surgery is performed.
Receives: Drug: 5FU, 250 mg/m2; Drug: 5FU, 2400 mg/m2; Drug: Oxaliplatin 50 mg/m2; Drug: Folinic Acid, 400 mg/m2; Drug: Capecitabine, 1000 mg/m2; Drug: Oxaliplatin 85 mg/m2; Radiation: radiotherapy experimental, 30 x 1,8 Gy: 54 Gy; Drug: Capecitabine, 825 mg/m2; Drug: Oxaliplatin, 130 mg/m2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. organ preservation

    it is defined as follows: survival with rectum intact, no major surgery, no stoma. Accordingly, the primary endpoint, organ preservation, will not be reached if any of the following occurs: (1) death, (2) any major surgery other than local excision (R0) performed after randomization, during TNT, at re-staging scheduled 22-24 weeks after start of TNT due to clinical non-cCR, or for any locoregional regrowth after initial cCR requiring salvage-TME, (3) any locoregional regrowth not amenable to salvage surgery, or (4) any stoma (non-re-converted protective stoma within 6 months after completion of TNT, or any stoma needed for toxicity or poor function), whichever occurs first.

    Measured: 3 years

Secondary outcomes (21)

  1. Disease-free survival

    Disease-free survival

    Measured: 3 years

  2. Rate of clinical complete response after TNT:

    TNT total neoadjuvant therapy

    Measured: 3 years

  3. Rate of immediate TME after TNT

    TNT total neoadjuvant therapy TME total mesorectal excision

    Measured: 3 years

  4. Cumulative incidence of locoregional regrowth after cCR

    cCR clinical complete response

    Measured: 3 years

  5. Rate of salvage surgery (LE/TME with or APR/stoma) after locoregional regrowth APR/stoma) after locoregional regrowth

    LE local Exision; TME: Transanale endoscopic Mikrochirurgie; APR Abdomino perineal Rectum exstirpation

    Measured: 3 years

  6. Cumulative incidence of local recurrence after (salvage) surgery surgery

    Cumulative incidence of local recurrence after (salvage) surgery

    Measured: 3 years

  7. Postoperative complications of (salvage) surgery

    Postoperative complications of (salvage) surgery

    Measured: 3 years

  8. Rate of sphincter-sparing (salvage) surgery

    Rate of sphincter-sparing (salvage) surgery

    Measured: 3 years

  9. Pathological TNM-staging

    Pathological tumor evaluations;TNM tumor staging

    Measured: 3 years

  10. R0 resection rate; negative circumferential resection rate

    R0 Removal of the tumor in healthy tissue

    Measured: 3 years

  11. Tumor regression grading according to Dworak

    pathological response from scale 1-4 poor to very good ascending

    Measured: 3 years

  12. Neoadjuvant rectal score

    Neoadjuvant rectal score from low to high values means good to poor

    Measured: 3 years

  13. Quality of TME according to MERCURY

    Tumor response using MRI scale 1-5 from good to poor descending

    Measured: 3 years

  14. Acute and late toxicity assessment according to NCI CTCAE V.5.0) CTCAE V.5.0)

    CTCAE V.5.0

    Measured: 3 Yeears

  15. Quality of life C30 based on treatment arm and surgical procedures/organ preservation

    Quality of life based on EORTC-QLQs-C30

    Measured: 3 years

  16. functional outcome based on treatment arm and surgical procedures/organ preservation

    functional outcome based on Wexner score

    Measured: 3 years

  17. Quality of life CR29 based on treatment arm and surgical procedures/organ preservation

    Quality of life based on EORTC-QLQs-CR29

    Measured: 3 years

  18. Quality of life CPIN 20 based on treatment arm and surgical procedures/organ preservation

    Quality of life based on EORTC-QLQs-CPIN20 Quality of life based on EORTC-QLQs-CPIN20

    Measured: 3 years

  19. Cumulative incidence of distant metastases

    Cumulative incidence of distant metastases

    Measured: 3 Years

  20. Overall survival

    Overall survival

    Measured: 3 years

  21. Translational / biomarker studies

    The translational research program will include proteomics, genomics and immune profile assessment in primary tumor samples as well as peripheral bloods samples (liquid biopsy).

    Tumor tissue samples and blood will be collected, processed and stored using protocols.

    Primary tumor tissue with either fresh tissue or formalin-fixed, paraffin-embedded (FFPE) tissue will be collected at two different time points: i) preoperative biopsy; ii) before/during surgical resection. Peripheral blood samples will be stored at three different time points: i) immediately before initiation of preoperative treatment (day 1); ii) during therapy assessment at week 22-24 and iii) at the time point of the first follow up.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2020
  2. Study start5 Nov 2020
  3. Primary completion15 Sep 2026 (estimated)
  4. Study completion15 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Investigator-driven
Masking
Single blind
Who is masked
Investigator
Enrolment
702 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04246684
Sponsor's protocol ID
ACO/ARO/AIO-18.1
Status last verified
Aug 2026
First submitted
23 Jan 2020
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Szeglin B, Consul MS, Breckheimer MC, Whitbread JJ Jr, Stem M, Gabre-Kidan AA, Bafford AC, Migaly J. Short- Versus Long-Course Radiation in Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: A Propensity-Matched National Cancer Database Analysis. Dis Colon Rectum. 2026 Nov 1;69(11):2639-2648. doi: 10.1097/DCR.0000000000004374. Epub 2026 Aug 14.

    PubMed 42598830

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oxaliplatin, 85 mg/m2, 5FU; 2400 mg/m2 and 5FU, 250 mg/m2 in people with Rectal Cancer Stage III, run by Prof. Dr. med. Claus Rödel at 75 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

organ preservation (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04246684, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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