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Colorectal Liver MetastasisARMANINCT04678583

Anatomical Resection of Liver MetAstases iN patIents With RAS-mutated Colorectal Cancer

A study testing Resection of colorectal liver metastases in people with Colorectal Liver Metastasis, run by Technische Universität Dresden at 37 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

the ARMANI trial will test the hypothesis, if an anatomic resection (AR) improves long-term outcome vs. a non-anatomical resection (NAR) in patients undergoing surgery for RAS-mutated colorectal liver metastasis (CRLM). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Liver Metastasis
What is being tested?
Resection of colorectal liver metastases
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
37 sitesGermany
Study dates
1 Jan 2021to Dec 2027
Phase
Interventional
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

  • Colorectal cancer with RAS mutation (KRAS or NRAS)
  • Colorectal liver metastases (single or multiple)
  • Planned R0 resection of liver metastases (and primary tumor, if present)
  • Anatomical and non-anatomical liver resection technically feasible
  • Male and female patients, age ≥ 18 years
  • Written informed consent

Who cannot join

  • Extrahepatic metastases
  • Planned staged liver resection (e.g. two-stage hepatectomy)
  • Diagnosis of another cancer < 5 years prior to randomization Exceptions: curatively treated in situ cervical cancer, curatively resected non-melanoma skin cancer
  • Expected lack of compliance
  • Addiction or other illnesses which do not allow the person concerned to assess the nature and extent of the clinical trial and its possible consequences

Trial locations and contacts

37 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jürgen Weitz, Prof Dr med contact

+49-(0)351 458 4850

juergen.weitz@ukdd.de

37 sites in 1 country

Germany37 sites, 36 recruiting

  • Intestinal Center West Middle Franconia, ANregiomed Clinic Ansbach

    Ansbach

    Recruiting

  • Clinic for General, Vizeral and Transplant Surgery, Augsburg University Hospital

    Augsburg

    Recruiting

  • Department of General, Visceral and Vascular Surgery, Charité, University Medicine Berlin, Campus Benjamin Franklin Berlin

    Berlin

    Recruiting

  • Clinic and Polyclinic for General, Visceral, Thoracic and Vascular Surgery, University Hospital Bonn

    Bonn

    Recruiting

  • Surgical Clinic, Municipal Hospital Braunschweig gGmbH

    Braunschweig

    Recruiting

  • Cancer Center, Helios Amper-Hospital Dachau

    Dachau

    Recruiting

  • Surgical Clinic, Dortmund Hospital

    Dortmund

    Recruiting

  • Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden

    Dresden, Saxony, 01307

    Jürgen Weitz, Prof Dr med

    Secretary, +49-(0)351 458 4850

    Recruiting

  • Clinic for General and Visceral Surgery, Municipal Hospital Dresden

    Dresden

    Recruiting

  • Clinic for General, Visceral and Pediatric Surgery, University Hospital Düsseldorf

    Düsseldorf

    Recruiting

  • Surgical Clinic, University Hospital Erlangen

    Erlangen

    Recruiting

  • Clinic for General, Visceral and Transplant Surgery, University Hospital Frankfurt, Goethe University Frankfurt am Main

    Frankfurt

    Recruiting

  • Department for General and Visceral Surgery, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg

    Freiburg im Breisgau

    Recruiting

  • JLU Gießen, Department for General, Visceral, Thoracic and Transplant Surgery

    Giessen

    Recruiting

  • Clinic for General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Georg-August-University

    Göttingen

    Recruiting

  • Clinic and Polyclinic for General Surgery, Department of Gastrointestinal, Thoracic and Vascular Surgery, University Greifswald, University Hospital Greifswald

    Greifswald

    Recruiting

  • University Hospital and Polyclinic for Visceral, Vascular and Endocrine Surgery, University Hospital Halle (Saale)

    Halle

    Recruiting

  • Center for Surgical Medicine - Clinic and Polyclinic for General, Visceral and Thoracic Surgery, University Hospital Hamburg-Eppendorf

    Hamburg

    Recruiting

  • Department of Liver, Bile Duct and Pancreas Surgery, University Department of surgery, Asklepios Klinik Barmbek

    Hamburg

    Recruiting

  • Clinic for General, Visceral and Minimally Invasive Surgery, KRH Clinic Siloah, Hannover

    Hanover

    Recruiting

  • Medizinische Hochschule Hannover, Department of General, Visceral and Transplant Surgery

    Hanover

    Recruiting

  • Department of General, Visceral and Transplantation Surgery, University of Heidelberg

    Heidelberg

    Recruiting

  • General Visceral and Vascular Surgery, Jena University Medical Center

    Jena

    Recruiting

  • Clinic for Surgery, University Hospital Schleswig-Holstein Lübeck Campus

    Lübeck

    Recruiting

  • University Department of General, Visceral, Vascular and Transplant Surgery, Faculty of Medicine, Otto von Guericke University Magdeburg

    Magdeburg

    Recruiting

  • Clinic for General, Visceral and Transplantation Surgery, University Medical Center of the Johannes Gutenberg-University Mainz

    Mainz

    Recruiting

  • Department of Surgery at the University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University

    Mannheim, Baden-Wurttemberg, 68167

    Recruiting

  • Clinic for Visceral, Thoracic and Vascular Surgery, University Hospital Giessen and Marburg

    Marburg

    Recruiting

  • Department Hepato-Pancreato-Biliary Surgery, Barmherzige Brüder gGmbH of the Hospital Barmherzige Brüder Munich

    München

    Recruiting

  • Department of Surgery, University Hospital rechts der Isar

    München

    Recruiting

  • LMU Munich Hospital, Clinic for General, Visceral and Transplant Surgery

    Munich

    Recruiting

  • Clinic for General, Visceral and Transplant Surgery, University of Münster

    Münster

    Recruiting

  • University Hospital for General and Visceral Surgery, Oldenburg Hospital

    Oldenburg

    Withdrawn

  • Department of General, Visceral and Transplant Surgery, University of Tübingen, Comprehensive Cancer Center

    Tübingen

    Recruiting

  • Clinic for General and Visceral Surgery, Ulm University Medical Center

    Ulm

    Recruiting

  • General and Visceral Surgery, Helios University Medical Center Wuppertal, University Witten/Herdecke

    Wuppertal

    Recruiting

  • Department for General, Visceral, Transplant, Vascular and Pediatric Surgery, Julius-Maximilian-University Würzburg, University Hospital Würzburg

    Würzburg

    Recruiting

Other trials in Germany

About this study

the ARMANI trial will test the hypothesis, if an anatomic resection (AR) improves long-term outcome vs. a non-anatomical resection (NAR) in patients undergoing surgery for RAS-mutated colorectal liver metastasis (CRLM).

Read the detailed description

Despite increasing application and success of personalized treatment in medical oncology, little progress has been made in personalized surgical cancer therapy. The ARMANI trial presents the first prospective, randomized trial to evaluate effectiveness and safety of molecular-guided resection in patients with colorectal liver metastasis (CRLM). While CRLM might be removed independently of the liver's segmental borders, retrospective data favor anatomic resections in the subgroup of patients with a mutation in the RAS oncogene. Therefore, the ARMANI trial will test the hypothesis, if an anatomic resection (AR) improves long-term outcome vs. a non-anatomical resection (NAR) in patients undergoing surgery for RAS-mutated CRLM. The trial will be carried out among 11 high-volume centers of hepato-biliary surgery in Germany. A total of 220 patients will be enrolled and randomized in a 1:1 ratio to undergo an AR vs. NAR. The primary endpoint is intrahepatic disease-free survival (iDFS). In addition, the study will provide important data on perioperative outcomes and quality of life for both surgical techniques. Given the trend among liver surgeons to aim for parenchymal-sparing operations to preserve liver parenchyma, a positive trial will be practice changing and present the first piece of high-level evidence on benefits of personalized surgical therapy guided by the tumor's mutational profile in patients with CRLM.

Being tested
Resection of colorectal liver metastases

What participants receive

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

  • Resection of colorectal liver metastasesProcedure or surgery

    Comparison of two liver surgery methods

Study groups in NCT04678583
Study groupRoleWhat they receive
A - Anatomical resectionExperimentalremoval of the entire, tumor-bearing liver segment(s)
Receives: Procedure: Resection of colorectal liver metastases
B - Non-anatomical resectionActive comparatormetastasectomy with a margin of healthy liver tissue irrespective of segmental borders
Receives: Procedure: Resection of colorectal liver metastases

What is being measured

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

  1. Intrahepatic disease-free survival (iDFS)

    Time from operation date to date of disease recurrence in the liver, followed up at intervals of three months for a maximum duration of 24 months or until death. Any new, solid lesion in the liver after resection of all CRLM that fulfils imaging criteria (CT, MRI) of a metastasis is counted as an iDFS event.

    Measured: 24 months

Secondary outcomes (25)

  1. Assessment of additional oncological and perioperative outcomes: Intraoperative blood loss [mL]

    Intraoperative blood loss presents the amount of blood lost from skin incision until skin closure. Spilling water and ascites will be subtracted. Swabs will be squeezed and their content will also be sucked and added to the fluid collected in the suction containers.

    Measured: During surgery

  2. Assessment of additional oncological and perioperative outcomes: Operating time [min]

    Time from skin incision until placement of last skin staple/suture.

    Measured: During surgery

  3. Assessment of additional oncological and perioperative outcomes: Transfusion of blood, transfused packed red blood cells (PRBC), fresh frozen plasma (FFP) and / or platelet concentrate (PC) [units]

    Administration of blood transfusions is documented for the intra- and postoperative period within 48 hours postoperatively.

    Measured: 48 hours after surgery

  4. Assessment of additional oncological and perioperative outcomes: Duration of postoperative hospital stay [days]

    Postoperative day 1 until day of discharge

    Measured: At day of discharge, assessed up to 90 days

  5. Assessment of additional oncological and perioperative outcomes: Duration of postoperative intermediate/intensive care unit stay [days]

    Days on the intermediate care unit (IMC) or intensive care unit (ICU) after surgery. Patient's stay in the recovery room exceeding 24 hours is counted as ICU stay

    Measured: At day of discharge, assessed up to 90 days

  6. Assessment of additional oncological and perioperative outcomes: Frequency of peri-operative morbidity after resection

    Frequency of peri-operative complications after resection of the primary tumor

    Measured: 90 days after surgery

  7. Assessment of additional oncological and perioperative outcomes: Kind of peri-operative morbidity after resection

    Kind of peri-operative complications after resection of the primary tumor

    Measured: 90 days after surgery

  8. Assessment of additional oncological and perioperative outcomes: 90-day mortality

    Death due to any cause within 90 days after surgery

    Measured: 90 days after surgery

  9. Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Platelet count

    Platelet count will be measured preoperatively and on postoperative day 5

    Measured: pre-operatively, 5 days after surgery

  10. Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Alanine-aminotransferase

    Levels of alanine-aminotransferase (ALT) will be measured preoperatively and on postoperative day 5

    Measured: pre-operatively, 5 days after surgery

  11. Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: aspartate-aminotransferase

    Levels of aspartate-aminotransferase (AST) will be measured preoperatively and on postoperative day 5

    Measured: pre-operatively, 5 days after surgery

  12. Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Gamma-glutamyl transferase

    Levels of Gamma-glutamyl transferase (GGT) will be measured preoperatively and on postoperative day 5

    Measured: pre-operatively, 5 days after surgery

  13. Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: International normalized ratio

    Levels of international normalized ratio (INR) will be measured preoperatively and on postoperative day 5

    Measured: pre-operatively, 5 days after surgery

  14. Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Total bilirubin

    Levels of total bilirubin will be measured preoperatively and on postoperative day 5

    Measured: pre-operatively, 5 days after surgery

  15. Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Albumin

    Levels of albumin will be measured preoperatively and on postoperative day 5

    Measured: pre-operatively, 5 days after surgery

  16. Assessment of additional oncological and perioperative outcomes: Frequency invasive re-interventions

    Invasive re-interventions such as placement of interventional drains, Endoscopic retrograde cholangiopancreatography (ERCP) with stent placement, chest tube placement, and re-laparotomy within 30 days after the index operation or during patients' initial hospital stay

    Measured: 30 days after surgery

  17. Assessment of additional oncological and perioperative outcomes: Kind of invasive re-interventions

    Invasive re-interventions such as placement of interventional drains, Endoscopic retrograde cholangiopancreatography (ERCP) with stent placement, chest tube placement, and re-laparotomy within 30 days after the index operation or during patients' initial hospital stay

    Measured: 30 days after surgery

  18. Assessment of additional oncological and perioperative outcomes: Number of patients with positive resection margins

    Detection of tumor at the resection margin will be counted as positive resection margin

    Measured: During surgery

  19. Assessment of additional oncological and perioperative outcomes: Frequency of Overall survival (OS)

    The overall survival of all patients is assessed between operation date to date of death of any cause

    Measured: 24 month

  20. Assessment of additional oncological and perioperative outcomes: Frequency of cancer-specific survival (CSS)

    The cancer-specific survival of all patients is assessed between operation date to date of death of colorectal cancer

    Measured: 24 months

  21. Assessment of additional oncological and perioperative outcomes: Frequency of disease-free survival (DFS)

    The disease-free survival of all patients is assessed from operation date to the date of either progressive or recurrent disease, or death of any cause

    Measured: 24 month

  22. Assessment of additional oncological and perioperative outcomes: Administration of adjuvant therapy [y/n]

    Adjuvant therapy is not recommended. However, the decision for adjuvant therapy is left at discretion of the local oncologist. The administration of adjuvant therapy and kind of chemotherapy protocols used will be documented for both groups.

    Measured: 24 month

  23. Assessment of additional oncological and perioperative outcomes: Frequency of oncological Re-interventions [y/n]

    Frequency of interventions for treatment of intra- and/or extrahepatic disease recurrence will be documented. These interventions include: Chemotherapy, Surgical resection, Local ablation (e.g. radiofrequency or microwave ablation, stereotactic irradiation), Selective internal radiotherapy (SIRT), other

    Measured: 24 month

  24. Assessment of additional oncological and perioperative outcomes: Kind of oncological Re-interventions [y/n]

    Kind of interventions for treatment of intra- and/or extrahepatic disease recurrence will be documented. These interventions include: Chemotherapy, Surgical resection, Local ablation (e.g. radiofrequency or microwave ablation, stereotactic irradiation), Selective internal radiotherapy (SIRT), other

    Measured: 24 month

  25. Assessment of additional oncological and perioperative outcomes: Assessment of "Quality of life" (QoL)

    Quality of life is measured preoperatively and at 90 days (± 7 days) and 12 months (± 7 days) postoperatively using the EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer; Questionnaire for the assessment of Quality of Life of Cancer patients with the module dedicated to colorectal liver metastases (EORTC QLQ-LMC21); the questionnaire assesses multi-item scales, each item scoring from 1 to 4, a high score represents a high level of symptomatology or problems.

    Measured: 12 month

Timeline

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

  1. First posted22 Dec 2020
  2. Study start1 Jan 2021
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, controlled, patient and observer-blinded, confirmatory trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04678583
Sponsor's protocol ID
VTG-08
Acronym
ARMANI
Status last verified
Jun 2024
First submitted
30 Oct 2020
Last updated
13 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Resection of colorectal liver metastases in people with Colorectal Liver Metastasis, run by Technische Universität Dresden at 37 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 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.

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?

Contact Jürgen Weitz, Prof Dr med (+49-(0)351 458 4850, juergen.weitz@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intrahepatic disease-free survival (iDFS) (time frame: 24 months). 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 NCT04678583.

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 13 Jun 2024.

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