No registrations found.
ID
Source
Brief title
Health condition
Metastatic colorectal cancer
Sponsors and support
Dept. of Medical Oncology
UMC Utrecht
PO Box 85500 (Q04.4.300),
3508 GA Utrecht, the Netherlands
Intervention
Outcome measures
Primary outcome
Response at first evaluation after treatment with standard of care drugs of the index metastasis that is biopsied for organoid culture as measured by change in size on a CT-scan (continuous variable).
Secondary outcome
Secondary endpoints:
• Response of the index metastasis at second and/or following evaluations (continuous variable)
• Response of the index metastasis dichotomized (< or >20% change in size)
• Response at patient level according to RECIST 1.1
• Progression-free survival
• Yield/feasibility of organoid culture
Background summary
N.A.
Study objective
Ex vivo organoid response correlates to in vivo response to standard first line treatment in mCRC patients on a metastasis level, therefore organoids can be used to predict response to therapy and select patients for a specific treatment.
Study design
For all patients, the treatment regimen(s) after biopsy will be recorded. The follow-up for treatment regimen(s) will be recorded until: 1) the end of treatment as determined by the end of follow up clinical visits or 2) death.
Response to treatment will be determined by evaluating the objective overall response rate (complete response and partial response) according to RECIST 1.1 criteria. Response to treatment will be evaluated through means of standard of care CT-scans. Follow-up CT scans will be performed according to institutional standards or at the physicians’ discretion. In addition, the biopsy from where the organoid originate is separately assessed for response.
Intervention
N.A.
Inclusion criteria
(Shortened)
1- Patients with histologically proven metastatic colorectal cancer who will receive first line systemic treatment.
2- Patient is included in PLCRC and has signed informed consent to be asked for future studies and blood withdrawal within PLCRC.
3- Patients need to have measurable RECIST CT imaging (according to RECIST 1.1) or evaluable disease (26).
4- Metastatic lesion(s) in the liver of which a biopsy can safely be obtained.
5- Patients not known with contraindications for lidocaine (or its derivatives).
6- Patients age > 18 years, willing and able to comply with the protocol as judged by the investigator with a signed informed consent.
If patients start a new line of treatment after participation in this trial, they are eligible to participate again. Informed consent, baseline screening and the histological biopsy procedure will have to be repeated.
Exclusion criteria
1- Patients with additional unrelated tumors.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7305 |
| NTR-old | NTR7521 |
| Other | : ABR NL61668.041.17 |