RecruitingPhase 2NCT06314997

Dynamic Changes in Circulating Tumour Cells Protein Expression

Dynamic Changes in RAS Gene Status and HER2 Expression in Circulating Tumour Cells: a Phase II Trial


Sponsor

Matteo's Friends

Enrollment

150 participants

Start Date

Jan 14, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This multicenter study, randomized, controlled of blood-based biomarker-driven targhet therapy. Patients were selectedm( at Hospital San Giovanni and Celio in Rome) according to CTCs results ( CTCs-guided managment performed at University Magna Graecia) or managed by the treating clinician according to standard pathological criteria (standard management). The participants were assigned to trial groups with the use of block randomization stratified according to the enrolling center location metropolitan) and tumor stage (T3 or T4).


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria2

  • Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 to 2 (scores range from 0 to 5, with higher numbers reflecting greater disability) ,
  • medically able to receive chemotherapy.

Exclusion Criteria3

  • evidence of infective disease before enrollment ,
  • a history of another primary cancer within the previous 3 years,
  • the presence of synchronous primary colorectal cancer.

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Interventions

DRUGpanitumumab (EGFR inhibitors)

Chemotherapy treatment includes anti-EGFR biologics such as cetuximab or panitumumab, antiangiogenic drugs such as bevacizumab or aflibercept. The indication to treat depends from the presence of CTCs analysed for Ras mutation and HER2 expression


Locations(1)

Natalia Malara

Germaneto, Italy

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NCT06314997