Dragon 2 - An international, randomized, controlled multicenter study comparing two different techniques aimed at increasing liver size.
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Basel, Luzern, Winterthur, Zürich
(BASEC)
Sponsor
nicht verfügbar
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Stefan Breitenstein
+41 52 266 42 15
stefan.breitenstein@clutterksw.ch(BASEC)
Allgemeine Auskünfte
Maastricht Universitair Medisch Centrum,
+31 638463945
stefan.breitenstein@clutterksw.ch(ICTRP)
Wissenschaftliche Auskünfte
Maastricht Universitair Medisch Centrum,
+31 638463945
stefan.breitenstein@clutterksw.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
09.01.2024
(BASEC)
ICTRP Studien-ID
NCT05428735 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
nicht verfügbar
Wissenschaftlicher Titel
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)
Öffentlicher Titel
The DRAGON 2 Trial (ICTRP)
Untersuchte Krankheit(en)
Colorectal Cancer Liver Metastases (CRLM);Small Future Liver Remnant (FLR) (ICTRP)
Untersuchte Intervention
Procedure: Embolization (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
Volume sufficient for resection at week 3 after the embolization;5-year Overall Survival (ICTRP)
nicht verfügbar
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Ronald M. van Dam, PhD;Sin?ad James, MD, PhD-candidate, sinead.james@mumc.nl, +31 638463945, Maastricht Universitair Medisch Centrum, (ICTRP)
Sekundäre IDs
NL80303.068.22 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05428735 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar