Status:
COMPLETED
CPCT-02 Biopsy Protocol
Lead Sponsor:
Foundation CPCT
Collaborating Sponsors:
Hartwig Medical Foundation
Conditions:
Solid Tumors
Metastatic Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A major challenge for researchers in cancer care is to expedite the development of new therapeutics and the Center for Personalized Cancer Treatment (a collaboration of the Dept. of Medical Oncology f...
Eligibility Criteria
Inclusion
- Selection criteria, defined as inclusion criteria, are:
- Patients with the following locally advanced or metastatic cancer for whom a new line of therapy is indicated below starting within 3 months after biopsy (see also table 2):
- \- Metastatic Pancreas Cancer: FOLFIRINOX (Folinic acid \[leucovorin\] + Fluorouracil \[5-FU\] + Irinotecan + Oxaliplatin)
- Measurable metastatic or locally advanced lesion(s), according to RECIST 1.1 criteria18. Guidelines for response evaluation are given in appendix A.
- Metastatic or locally advanced lesion(s) of which a histological biopsy can safely be obtained.
- Patients age \> 18 years, willing and able to comply with the protocol as judged by the investigator with a signed informed consent.
- Patients must meet selection criteria 3 not only prior to baseline biopsy, but also prior to the (optional and if applicable, see CPCT-02 Study manual) post-treatment biopsies.
- Exclusion criteria:
- \* If one or more of the above mentioned inclusion criteria is not met
Exclusion
Key Trial Info
Start Date :
August 17 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2023
Estimated Enrollment :
6927 Patients enrolled
Trial Details
Trial ID
NCT01855477
Start Date
August 17 2011
End Date
December 18 2023
Last Update
July 19 2024
Active Locations (1)
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1
Foundation CPCT, Radboud UMC
Nijmegen, South Holland, Netherlands, 6500 HB