Status:
UNKNOWN
RAS Mutations in ctDNA and Anti-EGFR reINTROduction in mCRC (RASINTRO)
Lead Sponsor:
Association des Gastroentérologues Oncologues
Collaborating Sponsors:
Hôpital Européen George Pompidou, APHP, Paris, France
UMR-S1147, Université Paris Descartes
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
Some data have suggested a clinical survival benefit related to the reintroduction of anti-EGFRs therapy in patients with metastatic colorectal cancer (mCRC). Based on resistance mechanisms related to...
Detailed Description
Somatic mutations in KRAS exon 2 are considered as a predictive marker of lack of efficacy for anti-EGFR therapy (panitumumab or cetuximab) in patients with metastatic colorectal cancer. Recently, it ...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Metastatic colorectal cancer histological confirmed without somatic mutations of KRAS (exons 2, 3 et 4) and NRAS (exons 2, 3 et 4)
- Apart from contraindication, patients should have already received fluoropyrimidine, irinotecan, oxaliplatin, anti-EGFR (panitumumab or cetuximab) and anti-angiogenic (bevacizumab or aflibercept) therapies
- Previous treatment with anti-EGFR-based chemotherapy (panitumumab or cetuximab) should have provided an objective tumor response (according to RECIST 1.1 criteria) and/or PFS ≥ 4 months.
- At least one line of interval chemotherapy between the last cycle of anti-EGFR based treatment and reintroduction of anti-EGFR therapy
- Signed written informed consent obtained prior to any study specific screening procedures
Exclusion
- Discontinuation of first anti-EGFR therapy for other reasons than tumor progression
- Previous malignancy other than colorectal cancer in the last 5 years
- Medical, sociological, psychological or legal conditions that would not permit the patient to sign the informed consent
Key Trial Info
Start Date :
October 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT03259009
Start Date
October 1 2017
End Date
June 1 2020
Last Update
September 11 2017
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