Optimization of Individualized Therapy for CRCs With Secondary RESISTance Towards Anti-EGFR Targeted Therapy Using an Avatar Model

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03263663

Studienbeginn:
Januar 2017

Letztes Update:
28.08.2017

Wirkstoff:
targeted substance according to the avatar model

Indikation (Clinical Trials):
Rectal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
PD Dr. med. Volker Heinemann

Collaborator:
MGO Ruhr-University Bochum (RUB)

Studienleiter

Sebastian Stintzing, Prof. Dr.
Principal Investigator
Senior Physician

Kontakt

Sebastian Stintzing, Prof. Dr.
Kontakt:
Phone: +49 89 4400 0
E-Mail: sebastian.stintzing@med.uni-muenchen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University of Munich - Klinikum der Universitaet Muenchen
81379 Munich
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Sebastian Stintzing, Prof. Dr.
Phone: +49 89 4400 0
E-Mail: sebastian.stintzing@med.uni-muenchen.de» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

In this exploratory phase II trial, the possibility of a personalized treatment after

resistance to cetuximab will be evaluated. Therefore, tumor material of all patients shall be

obtained, transferred into avatars and treated the same way as in the patient until

resistance arises. These resistant tumor cells are subsequently treated by different targeted

treatment combinations in the mouse avatar model to find the most active drug or combination

of drugs. This drug or combination of drugs may then be offered to the patient after

cetuximab resistance has occurred. Multiple liquid biopsies shall be obtained in patients

during first-line treatment with cetuximab as well as during second line experimental

treatment to monitor mutations that may be associated with cetuximab resistance. Furthermore

at the time of resistance a biopsy should be taken and analyzed to ensure that the mechanism

of resistance seen in the avatar model matches with the mechanism of resistance in the

individual patient.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Male and female patients age ≥ 18 years

- Written declaration of consent

- ECOG Performance Status 0-1

- Life expectancy> 3 months

- Histologically confirmed adenocarcinoma of the colon or rectum at stage UICC III or

UICC IV

- Histologically confirmed adenocarcinoma of the colon or rectum in stage UICC II with

one of the following risk factors: CEA> 200; T4 tumor, emergency surgery, <12 distant

lymph nodes, surgery due to intestinal obstruction (ileus)

- Patient agrees to the preservation of tumor material for the purpose of molecular

analyzes including the determination of the genetic profile of the tumor

(participation in the project "RESIST")

Exclusion Criteria:

- Preoperative Radiotherapy

- Preoperative chemotherapy

- Heart failure> Grade II (functional NYHA classification)

- Existing concomitant disease or condition that would make the patient unsuitable for a

study participation or interfere with the safety of the subject

- Any psychological, familial, sociological or geographical event which does not allow

observance of the study protocol

- Additional carcinoma therapy (chemotherapy, radiation, biological therapy,

immunotherapy or hormonal therapy) during the study

- Known malignant second neoplasia within the last 5 years (except for a basal cell

carcinoma or a carcinoma in situ of the uterine cervix).

Studien-Rationale

Primary outcome:

1. Progression-free-survival (Time Frame - 5-7 months):
according to RECIST 1.1

Studien-Arme

Chemotherapy plus targeted treatment
Patients are treated in second-line with chemotherapy plus a targeted treatment according to the resistance mechanism to cetuximab pretreatment
Chemotherapy according to physician choice standard
Patients are treated in second-line with chemotherapy according to physicians choice after cetuximab pretreatment

Geprüfte Regime

targeted substance according to the avatar model:
individualized second line treatment

Quelle: ClinicalTrials.gov

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