Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03369041 |
| Other study ID # |
DEBIRI Cohort |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 3, 2016 |
| Est. completion date |
October 15, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
Federation Francophone de Cancerologie Digestive |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
In order to extract the profiles of patients receiving DEBIRI treatment at best, the
investigators proposed the establishment of a national prospective cohort to collect
information on the greatest number of patients treated with DEBIRI. This cohort will allow a
better understanding of the effectiveness, tolerance, feasibility and differences of
practices at national level for this approach. These data will assist in the development of
clinical trials in situations that appear to be most promising in clinical practice.
Description:
Colorectal cancer (CRC) is the third most common cancer in men and the second in women (1.23
million cases in 2008, 608700 deaths) 40 to 50% of patients developed hepatic, synchronous or
metachronous metastases. In 10 to 15% of cases, these metastases are operable initially, and
a perioperative chemotherapy of the FOLFOX type is then most performed. In about 20% of
patients discharged metastases resectable after induction chemotherapy. When hepatic invasion
makes a complete resection impossible, a palliative treatment is initiated, mainly based on
chemotherapy with or without biotherapies (anti-VEGF or anti-EGFR).
In recent years, intra-hepatic arterial treatments have been developed, with the aim of
improving the prognosis of inoperable patients. The particular vascular anatomy of the liver
makes it possible to perform local work via its main artery or its branches. The hepatic
artery provides 25% of the blood flow and 50% of the oxygenation of the liver, the portal
vein ensures 75% of the blood flow and also 50% of the oxygenation. Primary or secondary
tumors are mainly focused on the artery and the rest of the parenchyma mainly through the
portal vein, treatment of tumors using the arterial route also allows to administer under
satisfactory safety conditions the therapeutic agent of Many More selective within the tumor,
saves healthy hepatic tissue.
Several approaches to intra-arterial treatments have been developed to date, such as hepatic
intra-arterial chemotherapy, radioembolization, or micro-bead embolization (DC-Beads®). In
the latter case, they are DEB Drug Eluting Beads at irinotecan, in the context of a treatment
called DEBIRI. Thanks to their diameter of 75 to 300 μm, they allow embolization of the
tumor's arterioles, with a dual objective: to create tumor ischemia and increase the
intra-tumor concentration in chemotherapy. The advantage of this approach is simplicity.
Contrary to the two previous techniques (radio and chemo-embolization), it does not require
the placement of an intra-arterial catheter, nor the administration of a radioactive agent
imposing heavy use constraints. It could make this intra-arterial technique accessible in
many centers and thus benefit a greater number of patients.
Data on the use of this strategy remain limited, and concern patients already treated by
several lines of chemotherapy. The response rates in these heavily pretreated patients are
encouraging.
Several questions arise: firstly, what is the place of this treatment used so far in patients
treated with the treatises (2 tests currently published). In practice, few patients have
limited liver disease after 2 or 3 lines of chemotherapy, which reserves this approach for a
small minority of patients. It should be tried to develop this technique earlier in the cost
of patients, in order to propose, for example, as a consolidation treatment in patients who
are not resectable or to try to have a down-sizing in potentially resectable patients.
Response rate of 65% in pretreated patients.
Other questions remain unanswered about this therapeutic approach: should systemic treatment
with 5FU be used to reduce the risk of extrahepatic progression? Is it possible, and can the
investigators associate, systemic chemotherapy such as oxaliplatin to intensify the response?
And finally, what is the place of biotherapies in this strategy? None of the questions have
been discussed with DEBIRI to date.
In order to extract the profiles of patients receiving DEBIRI treatment at best, the
investigators propose the establishment of a national prospective cohort to collect
information on the greatest number of patients treated with DEBIRI. This cohort has allowed a
better understanding of the effectiveness, tolerance, feasibility and differences of
practices at national level for this approach. These data will assist in the development of
clinical trials in situations that appear to be most promising in clinical practice.
