Status:
UNKNOWN
Aflibercept or Bevacizumab as Second-line Treatment of RAS Mutated Metastatic Colorectal Cancer
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-75 years
Brief Summary
Colorectal cancer is the third most frequent neoplasm after prostate and lung in man and breast and lung cancers in woman from Western Countries. The intensive study of predictive factors has strongly...
Eligibility Criteria
Inclusion
- Cytological or histological diagnosis of RAS mutated mCRC;
- progression at first-line chemotherapy with fluoropyrimidines, oxaliplatin and bevacizumab;
- stage IV;
- age \<75 years;
- ECOG Performance Status 0 or 1;
- life expectancy\> 3 months;
- negative pregnancy test for all potentially childbearing women.
Exclusion
- presence of primary non-treated stenosing colorectal neoplasm;
- active or uncontrolled infections or bleedings;
- other concomitant uncontrolled diseases or blood laboratory values contraindicating the study drugs at clinician evaluation;
- presence of brain metastases;
- refusal or inability to provide informed consent;
- impossibility to guarantee follow-up.
Key Trial Info
Start Date :
May 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 11 2024
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04397601
Start Date
May 11 2020
End Date
May 11 2024
Last Update
May 21 2020
Active Locations (1)
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1
SSD-Terapie Innovative Metastasi Addominali, Dipartimento di Oncologia Addominale, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale".
Naples, Italy, 80131