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| Name | Class |
|---|---|
| German Cancer Research Center | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - Anatomical resection | Experimental | removal of the entire, tumor-bearing liver segment(s) |
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| B - Non-anatomical resection | Active Comparator | metastasectomy with a margin of healthy liver tissue irrespective of segmental borders |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resection of colorectal liver metastases | Procedure | Comparison of two liver surgery methods |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jürgen Weitz, Prof Dr med | Contact | +49-(0)351 458 4850 | juergen.weitz@ukdd.de |
| Name | Affiliation | Role |
|---|---|---|
| Jürgen Weitz, Prof Dr med | Department of Gastrointestinal-, Thoracic and Vascular Surgery, University Hospital CGC | Principal Investigator |
| Nuh Rahbari, Prof Dr med | Allgemein- und Viszeralchirugie, University Hospital Ulm |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery at the University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University | Recruiting | Mannheim | Baden-Wurttemberg | 68167 | Germany |
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Randomized, controlled, patient and observer-blinded, confirmatory trial
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| Assessment of additional oncological and perioperative outcomes: Operating time [min] | Time from skin incision until placement of last skin staple/suture. | During surgery |
| 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. | 48 hours after surgery |
| Assessment of additional oncological and perioperative outcomes: Duration of postoperative hospital stay [days] | Postoperative day 1 until day of discharge | At day of discharge, assessed up to 90 days |
| 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 | At day of discharge, assessed up to 90 days |
| 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 | 90 days after surgery |
| 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 | 90 days after surgery |
| Assessment of additional oncological and perioperative outcomes: 90-day mortality | Death due to any cause within 90 days after surgery | 90 days after surgery |
| Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Platelet count | Platelet count will be measured preoperatively and on postoperative day 5 | pre-operatively, 5 days after surgery |
| 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 | pre-operatively, 5 days after surgery |
| 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 | pre-operatively, 5 days after surgery |
| 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 | pre-operatively, 5 days after surgery |
| 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 | pre-operatively, 5 days after surgery |
| 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 | pre-operatively, 5 days after surgery |
| Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Albumin | Levels of albumin will be measured preoperatively and on postoperative day 5 | pre-operatively, 5 days after surgery |
| 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 | 30 days after surgery |
| 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 | 30 days after surgery |
| 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 | During surgery |
| 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 | 24 month |
| 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 | 24 months |
| 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 | 24 month |
| 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. | 24 month |
| 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 | 24 month |
| 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 | 24 month |
| 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. | 12 month |
| Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden | Recruiting | Dresden | Saxony | 01307 | Germany |
|
| Intestinal Center West Middle Franconia, ANregiomed Clinic Ansbach | Recruiting | Ansbach | Germany |
| Clinic for General, Vizeral and Transplant Surgery, Augsburg University Hospital | Recruiting | Augsburg | Germany |
| Department of General, Visceral and Vascular Surgery, Charité, University Medicine Berlin, Campus Benjamin Franklin Berlin | Recruiting | Berlin | Germany |
| Clinic and Polyclinic for General, Visceral, Thoracic and Vascular Surgery, University Hospital Bonn | Recruiting | Bonn | Germany |
| Surgical Clinic, Municipal Hospital Braunschweig gGmbH | Recruiting | Braunschweig | Germany |
| Cancer Center, Helios Amper-Hospital Dachau | Recruiting | Dachau | Germany |
| Surgical Clinic, Dortmund Hospital | Recruiting | Dortmund | Germany |
| Clinic for General and Visceral Surgery, Municipal Hospital Dresden | Recruiting | Dresden | Germany |
| Clinic for General, Visceral and Pediatric Surgery, University Hospital Düsseldorf | Recruiting | Düsseldorf | Germany |
| Surgical Clinic, University Hospital Erlangen | Recruiting | Erlangen | Germany |
| Clinic for General, Visceral and Transplant Surgery, University Hospital Frankfurt, Goethe University Frankfurt am Main | Recruiting | Frankfurt | Germany |
| Department for General and Visceral Surgery, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg | Recruiting | Freiburg im Breisgau | Germany |
| JLU Gießen, Department for General, Visceral, Thoracic and Transplant Surgery | Recruiting | Giessen | Germany |
| Clinic for General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Georg-August-University | Recruiting | Göttingen | Germany |
| Clinic and Polyclinic for General Surgery, Department of Gastrointestinal, Thoracic and Vascular Surgery, University Greifswald, University Hospital Greifswald | Recruiting | Greifswald | Germany |
| University Hospital and Polyclinic for Visceral, Vascular and Endocrine Surgery, University Hospital Halle (Saale) | Recruiting | Halle | Germany |
| Center for Surgical Medicine - Clinic and Polyclinic for General, Visceral and Thoracic Surgery, University Hospital Hamburg-Eppendorf | Recruiting | Hamburg | Germany |
| Department of Liver, Bile Duct and Pancreas Surgery, University Department of surgery, Asklepios Klinik Barmbek | Recruiting | Hamburg | Germany |
| Clinic for General, Visceral and Minimally Invasive Surgery, KRH Clinic Siloah, Hannover | Recruiting | Hanover | Germany |
| Medizinische Hochschule Hannover, Department of General, Visceral and Transplant Surgery | Recruiting | Hanover | Germany |
| Department of General, Visceral and Transplantation Surgery, University of Heidelberg | Recruiting | Heidelberg | Germany |
| General Visceral and Vascular Surgery, Jena University Medical Center | Recruiting | Jena | Germany |
| Clinic for Surgery, University Hospital Schleswig-Holstein Lübeck Campus | Recruiting | Lübeck | Germany |
| University Department of General, Visceral, Vascular and Transplant Surgery, Faculty of Medicine, Otto von Guericke University Magdeburg | Recruiting | Magdeburg | Germany |
| Clinic for General, Visceral and Transplantation Surgery, University Medical Center of the Johannes Gutenberg-University Mainz | Recruiting | Mainz | Germany |
| Clinic for Visceral, Thoracic and Vascular Surgery, University Hospital Giessen and Marburg | Recruiting | Marburg | Germany |
| LMU Munich Hospital, Clinic for General, Visceral and Transplant Surgery | Recruiting | Munich | Germany |
| Department Hepato-Pancreato-Biliary Surgery, Barmherzige Brüder gGmbH of the Hospital Barmherzige Brüder Munich | Recruiting | München | Germany |
| Department of Surgery, University Hospital rechts der Isar | Recruiting | München | Germany |
| Clinic for General, Visceral and Transplant Surgery, University of Münster | Recruiting | Münster | Germany |
| University Hospital for General and Visceral Surgery, Oldenburg Hospital | Withdrawn | Oldenburg | Germany |
| Department of General, Visceral and Transplant Surgery, University of Tübingen, Comprehensive Cancer Center | Recruiting | Tübingen | Germany |
| Clinic for General and Visceral Surgery, Ulm University Medical Center | Recruiting | Ulm | Germany |
| General and Visceral Surgery, Helios University Medical Center Wuppertal, University Witten/Herdecke | Recruiting | Wuppertal | Germany |
| Department for General, Visceral, Transplant, Vascular and Pediatric Surgery, Julius-Maximilian-University Würzburg, University Hospital Würzburg | Recruiting | Würzburg | Germany |