Anatomical Resection of Liver MetAstases iN patIents With RAS-mutated Colorectal Cancer (ARMANI)
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ClinicalTrials.gov Identifier: NCT04678583 |
Recruitment Status :
Recruiting
First Posted : December 22, 2020
Last Update Posted : February 16, 2024
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Condition or disease | Intervention/treatment | Phase |
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Colorectal Liver Metastasis | Procedure: Resection of colorectal liver metastases | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized, controlled, patient and observer-blinded, confirmatory trial |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Anatomical Resection of Liver MetAstases iN patIents With RAS-mutated Colorectal Cancer |
Actual Study Start Date : | January 1, 2021 |
Estimated Primary Completion Date : | December 2027 |
Estimated Study Completion Date : | December 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: A - Anatomical resection
removal of the entire, tumor-bearing liver segment(s)
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Procedure: Resection of colorectal liver metastases
Comparison of two liver surgery methods |
Active Comparator: B - Non-anatomical resection
metastasectomy with a margin of healthy liver tissue irrespective of segmental borders
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Procedure: Resection of colorectal liver metastases
Comparison of two liver surgery methods |
- Intrahepatic disease-free survival (iDFS) [ Time Frame: 24 months ]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.
- Assessment of additional oncological and perioperative outcomes: Intraoperative blood loss [mL] [ Time Frame: During surgery ]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.
- Assessment of additional oncological and perioperative outcomes: Operating time [min] [ Time Frame: During surgery ]Time from skin incision until placement of last skin staple/suture.
- 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] [ Time Frame: 48 hours after surgery ]Administration of blood transfusions is documented for the intra- and postoperative period within 48 hours postoperatively.
- Assessment of additional oncological and perioperative outcomes: Duration of postoperative hospital stay [days] [ Time Frame: At day of discharge, assessed up to 90 days ]Postoperative day 1 until day of discharge
- Assessment of additional oncological and perioperative outcomes: Duration of postoperative intermediate/intensive care unit stay [days] [ Time Frame: At day of discharge, assessed up to 90 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
- Assessment of additional oncological and perioperative outcomes: Frequency of peri-operative morbidity after resection [ Time Frame: 90 days after surgery ]Frequency of peri-operative complications after resection of the primary tumor
- Assessment of additional oncological and perioperative outcomes: Kind of peri-operative morbidity after resection [ Time Frame: 90 days after surgery ]Kind of peri-operative complications after resection of the primary tumor
- Assessment of additional oncological and perioperative outcomes: 90-day mortality [ Time Frame: 90 days after surgery ]Death due to any cause within 90 days after surgery
- Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Platelet count [ Time Frame: pre-operatively, 5 days after surgery ]Platelet count will be measured preoperatively and on postoperative day 5
- Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Alanine-aminotransferase [ Time Frame: pre-operatively, 5 days after surgery ]Levels of alanine-aminotransferase (ALT) will be measured preoperatively and on postoperative day 5
- Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: aspartate-aminotransferase [ Time Frame: pre-operatively, 5 days after surgery ]Levels of aspartate-aminotransferase (AST) will be measured preoperatively and on postoperative day 5
- Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Gamma-glutamyl transferase [ Time Frame: pre-operatively, 5 days after surgery ]Levels of Gamma-glutamyl transferase (GGT) will be measured preoperatively and on postoperative day 5
- Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: International normalized ratio [ Time Frame: pre-operatively, 5 days after surgery ]Levels of international normalized ratio (INR) will be measured preoperatively and on postoperative day 5
- Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Total bilirubin [ Time Frame: pre-operatively, 5 days after surgery ]Levels of total bilirubin will be measured preoperatively and on postoperative day 5
- Assessment of additional oncological and perioperative outcomes: Liver biochemical tests: Albumin [ Time Frame: pre-operatively, 5 days after surgery ]Levels of albumin will be measured preoperatively and on postoperative day 5
- Assessment of additional oncological and perioperative outcomes: Frequency invasive re-interventions [ Time Frame: 30 days after surgery ]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
- Assessment of additional oncological and perioperative outcomes: Kind of invasive re-interventions [ Time Frame: 30 days after surgery ]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
- Assessment of additional oncological and perioperative outcomes: Number of patients with positive resection margins [ Time Frame: During surgery ]Detection of tumor at the resection margin will be counted as positive resection margin
- Assessment of additional oncological and perioperative outcomes: Frequency of Overall survival (OS) [ Time Frame: 24 month ]The overall survival of all patients is assessed between operation date to date of death of any cause
- Assessment of additional oncological and perioperative outcomes: Frequency of cancer-specific survival (CSS) [ Time Frame: 24 months ]The cancer-specific survival of all patients is assessed between operation date to date of death of colorectal cancer
- Assessment of additional oncological and perioperative outcomes: Frequency of disease-free survival (DFS) [ Time Frame: 24 month ]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
- Assessment of additional oncological and perioperative outcomes: Administration of adjuvant therapy [y/n] [ Time Frame: 24 month ]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.
- Assessment of additional oncological and perioperative outcomes: Frequency of oncological Re-interventions [y/n] [ Time Frame: 24 month ]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
- Assessment of additional oncological and perioperative outcomes: Kind of oncological Re-interventions [y/n] [ Time Frame: 24 month ]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
- Assessment of additional oncological and perioperative outcomes: Assessment of "Quality of life" (QoL) [ Time Frame: 12 month ]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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04678583
Contact: Jürgen Weitz, Prof Dr med | +49-(0)351 458 4850 | juergen.weitz@ukdd.de |
Principal Investigator: | 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 |
Responsible Party: | Technische Universität Dresden |
ClinicalTrials.gov Identifier: | NCT04678583 |
Other Study ID Numbers: |
VTG-08 |
First Posted: | December 22, 2020 Key Record Dates |
Last Update Posted: | February 16, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasm Metastasis Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Neoplastic Processes Pathologic Processes Liver Diseases |