Status:
UNKNOWN
Optimization of Individualized Therapy for CRCs With Secondary RESISTance Towards Anti-EGFR Targeted Therapy Using an Avatar Model
Lead Sponsor:
PD Dr. med. Volker Heinemann
Collaborating Sponsors:
MGO Ruhr-University Bochum (RUB)
Conditions:
Colo-rectal Cancer
RAS Wild-type
Eligibility:
All Genders
18+ years
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, transferre...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03263663
Start Date
January 1 2017
End Date
January 1 2025
Last Update
August 28 2017
Active Locations (1)
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1
University of Munich - Klinikum der Universitaet Muenchen
Munich, Bavaria, Germany, 81379