Dragon 2 - An international, randomized, controlled multicenter study comparing two different techniques aimed at increasing liver size.
Résumé de l'étude
In patients suffering from colon and/or rectal cancer with metastases to the liver, these metastases can be surgically removed. Before such an operation, it must be ensured that the remaining portion of the liver after the operation is sufficiently large. If not, the portion of the liver that will remain after the operation can be induced to increase in size using various techniques to enable the operation. This study compares two of these techniques. It takes place in several countries at different centers, and patients are randomly assigned to one technique or the other. The primary investigation is whether, with either technique, the portion of the liver that remains in the body after the operation has grown sufficiently in three weeks to allow for the operation. Additionally, it examines which group of patients has a better survival rate after 5 years.
(BASEC)
Intervention étudiée
The intervention being studied is called "double vein embolization." This involves closing the veins that drain the diseased part of the liver and those that supply it. This leads to better blood flow to the healthy portion of the liver, thereby promoting its growth. The intervention, that is, the closure of these veins, is performed on one hand via a catheter in the jugular vein, through which the veins draining the liver are accessed and closed with metal plugs under X-ray control. On the other hand, the veins leading to the liver are accessed through a direct puncture through the skin into the liver and closed with a liquid mixture of oil and synthetic resin. In the second group of patients, only the veins supplying the liver, as described above, are closed, which is the current standard treatment in these cases.
(BASEC)
Maladie en cours d'investigation
Metastases in the liver originating from colon and rectal cancer.
(BASEC)
- Patients with metastases from colon or rectal cancer in the liver that cannot be surgically removed or safely removed, as the future remainder of the liver after the operation is less than 30% of the total liver volume (less than 40% after prior chemotherapy) - If other metastases are present in the body (lung, brain), these must also be removable - Men and women aged 18 years and older (BASEC)
Critères d'exclusion
- Pregnant or breastfeeding women - Women of childbearing age who cannot or do not want to use contraception - Patients with further metastases outside the liver that cannot be removed or ablated (BASEC)
Lieu de l’étude
Bâle, Luzern, Winterthur, Zurich
(BASEC)
Sponsor
non disponible
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. med. Stefan Breitenstein
+41 52 266 42 15
stefan.breitenstein@clutterksw.ch(BASEC)
Informations générales
Maastricht Universitair Medisch Centrum,
+31 638463945
stefan.breitenstein@clutterksw.ch(ICTRP)
Informations scientifiques
Maastricht Universitair Medisch Centrum,
+31 638463945
stefan.breitenstein@clutterksw.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
09.01.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT05428735 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
non disponible
Titre académique
An International Multicenter Randomized Controlled Trial to Compare Combined Portal and Hepatic Vein Embolization (PVE/HVE) with PVE Alone in Patients with Colorectal Liver Cancer Metastases (CRLM) and a Small Future Liver Remnant (FLR) (ICTRP)
Titre public
The DRAGON 2 Trial (ICTRP)
Maladie en cours d'investigation
Colorectal Cancer Liver Metastases (CRLM);Small Future Liver Remnant (FLR) (ICTRP)
Intervention étudiée
Procedure: Embolization (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Patients with primarily unresectable/ potentially resectable CRLM with a FLR <30%
(<40% in chemotherapy damaged livers)
- Patients with non-resected primary CRC may be included if there is an intention to
resect the CRC after the liver treatment (liver first approach) or simultaneously
during one of the liver procedures.
- Patients with resectable or ablatable lung or brain metastases can be included
(statement about the resectability of these extrahepatic metastases by a tumor board
needs to be available)
- 18 Years and older
- Men and women
- Able to understand the trial and provide informed consent.
Exclusion Criteria:
- Pregnant or lactating female.
- Premenopausal females not able or willing to commit to oral contraception
- Patients with prohibitive comorbidities, decision made by local team
- Any patient with non-resectable or non-ablatable extrahepatic disease
- Patients with hepatic malignancies other than CRLM
- Progression of disease by RECIST criteria after cytoreduction chemotherapy
- Complete response after conversion chemotherapy
- Staging CT and (if indicated) CT/MRI brain that demonstrates non-resectable
extrahepatic disease
- The anatomy of the liver or manifestation of tumors in relation to the liver veins
prohibits the use of combined PVE/HVE. (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Volume sufficient for resection at week 3 after the embolization;5-year Overall Survival (ICTRP)
non disponible
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Ronald M. van Dam, PhD;Sin?ad James, MD, PhD-candidate, sinead.james@mumc.nl, +31 638463945, Maastricht Universitair Medisch Centrum, (ICTRP)
ID secondaires
NL80303.068.22 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05428735 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible