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JOURNAL ONKOLOGIE – STUDIE
DRAGON 2

The DRAGON 2 Trial

Rekrutierend

NCT-Nummer:
NCT05428735

Studienbeginn:
April 2022

Letztes Update:
27.07.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasm Metastasis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Maastricht University

Collaborator:
-

Studienleiter

Ronald M. van Dam, PhD
Principal Investigator
Maastricht Universitair Medisch Centrum

Kontakt

Studienlocations
(3 von 19)

Maastricht University Medical Center+
6229 HX Maastricht
NetherlandsNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Remon Korenblik, MD
Phone: +31637297507
E-Mail: remon.korenblik@mumc.nl

Ronald M van Dam, MD, PhD
E-Mail: r.van.dam@mumc.nl» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

Resection of liver metastases from colorectal cancer (CRLM) improves survival compared to

chemotherapy alone and may lead to cure in up to 40% of patients. Extended liver resections

are sometimes necessary to resect primarily unresectable/ potentially resectable (PU/PR)

colorectal liver metastases. These resections are generally performed if the volume of the

future liver remnant (FLR) comprises at least 30% of the total volume of the liver (without

the volume of the metastases) or when liver function of the FLR on technetium-99m (99mTc)

scintigraphy exceeds 2.67%/min/m2.

When this liver volume or function criterion is not met, a high chance of post-hepatectomy

liver failure exists. To prevent this, the induction of liver regeneration between a

two-stage hepatectomy is commonly performed.

The current standard procedure to induce regeneration is the embolization of the portal vein

branches to the tumor carrying liver (PVE) to induce hypertrophy of the remaining part of the

liver which will serve as the FLR. Recently, combined embolization of both portal and hepatic

veins (PVE/HVE) has been described as a possible superior alternative to PVE, as it increases

and accelerates hypertrophy of the FLR. PVE/HVE combines simultaneous embolization of the

main portal vein branches into the tumor carrying liver and the hepatic vein draining this

part of the liver. Preclinical studies in pigs, several retrospective studies, and the

prospective DRAGON 1 interim analysis (n=60) have demonstrated the safety and feasibility of

this novel technique. However, no international randomized controlled trial has been

performed, in which combined PVE/HVE is compared with PVE

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Volume sufficient for resection at week 3 after the embolization (Time Frame - 3 weeks):
Volume sufficient for resection will be based on the first week or third week CT/MR Volumetry. Vauthey calculation for TLV will be used and the FLR volume will be measured centrally (objective panel)

2. 5-year Overall Survival (Time Frame - 5 years):
survival data will be recorded up to 5-years.

Studien-Arme

  • Active Comparator: Portal Vein Embolization (PVE) alone - (control arm)
    Portal Vein Embolization (PVE) alone
  • Experimental: Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)
    Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)

Geprüfte Regime

  • Embolization:
    Portal Vein embolization with Glue by a transhepatic approach vs. PVE and Hepatic Vein Occlusion with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure

Quelle: ClinicalTrials.gov


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