Status:
COMPLETED
A Retrospective Study Project of Clinico-molecular Characterization in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Sara De Dosso
Collaborating Sponsors:
Istituto Cantonale di Patologia
Clinical Trial Unit Ente Ospedaliero Cantonale
Conditions:
Mestastatic ColoRectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This is a retrospective, translational, proof-of-concept study on tumor biopsies done on patients affected by mCRC and exhibiting RAS mutation. For each patient it will be selected the tissue biopsie...
Detailed Description
the study implies the subdivision into three groups with a 1:1:1 ratio. * The first group includes patients treated with surgery of the primary tumor, neoadjuvant chemotherapy plus bevacizumab and, f...
Eligibility Criteria
Inclusion
- General inclusion criteria (valid for all the three cohorts):
- patients with biopsy-proven, stage IV CRC;
- RAS mutation at diagnosis;
- availability of tissue biopsy/resection of both primary tumour and paired liver metastasis for the molecular characterization;
- General exclusion criteria (valid for all the three cohorts):
- inadequate material for the molecular characterization of the primary tumour and/or of the related metastasis;
- insufficient amount (%) of tumour cells;
- Specific inclusion criteria for each group:
- st group:
- first-line bevacizumab plus chemotherapy before resection of liver metastases;
- metastases must be resected metachronously with respect to the primary tumor.
- nd group:
- first-line chemotherapy without bevacizumab before resection of liver metastases;
- metastases must be resected metachronously with respect to the primary tumor.
- rd group:
- no systemic therapy (immediate surgical resection of primary tumor and paired liver metastases);
- primary tumour and metastasis can be synchronous or metachronous.
Exclusion
Key Trial Info
Start Date :
April 8 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 2 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04338542
Start Date
April 8 2020
End Date
July 2 2020
Last Update
August 11 2020
Active Locations (1)
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1
Istituto Oncologico della Svizzera Italiana
Bellinzona, Switzerland, 6500