CPCT-02 Biopsy Protocol

  • STATUS
    Recruiting
  • End date
    Dec 25, 2023
  • participants needed
    7000
  • sponsor
    Foundation CPCT
Updated on 25 January 2021
cancer
fluorouracil
metastasis
oxaliplatin
leucovorin
irinotecan
cancer treatment
targeted therapy
solid neoplasm
metastatic pancreatic cancer

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 from the University Medical Center Utrecht, Netherlands Cancer Center - Antoni van Leeuwenhoek hospital and the Erasmus Medical Center - Danil den Hoed clinic) is an initiative to achieve this goal.

The current and future generation anti-cancer drugs are developed to specifically activate or deactivate deregulated gene products or signaling pathways in cancer cells. The development of such "targeted" agents is an exciting new opportunity that promises to deliver more anti-cancer efficacy and less toxicity. Although targeted therapy has been a breakthrough in medical oncology leading to the development of a portfolio of potentially successful new drugs, it has not yet delivered the much needed relief for large patient populations. We believe that the development of these agents is mainly hampered by our lack of successful patient selection.

The CPCT aims to select patients for clinical trial participation based on the results of Next Generation Sequencing (NGS) information obtained from tumor material. The advent of NGS platforms enables us to probe a significant proportion of the cancer genome and thus to develop a realistic view on the complex genetic changes in cancer cells. The CPCT aims to use NGS platforms to improve the selection of patients for targeted therapy trials.

We will obtain tumor biopsies of a (preferably) metastatic or locally advanced lesion and peripheral blood sample from all patients included in the trial; the biopsies to obtain information on the tumor related genetic mutations (mutational profile) and the blood samples to assess each patient's germline DNA background variation. As patients will be asked to undergo an invasive procedure it is important to address the potential safety issues. Review of the literature shows that in general tumor biopsies can be performed with only minor complications and acceptable risks. We will recruit patients with metastatic or locally advanced (incurable) solid tumors and we aim to use the information obtained from DNA sequencing to stratify patients for inclusion in clinical trials. The final personalized treatment decision will be made dependent on the availability of trials and the expected predictive value of the mutational profile.

Details
Condition Metastasis, Bone Metastases, Metastatic Cancer, Brain Metastases, Liver Metastases, Neoplasm Metastasis, Liver Metastases, Bone Metastases, Solid Tumors, Solid Neoplasm, Brain Metastases, Solid Tumour, Cancer, Metastatic, Metastatic Cancer, Neoplasm Metastasis, metastases, metastatic disease, secondary cancer, secondaries, metastatic tumor, metastasized
Treatment Histological biopsy procedure
Clinical Study IdentifierNCT01855477
SponsorFoundation CPCT
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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