Dynamic Changes in Circulating Tumour Cells Protein Expression

Phase 2

Recruiting

• Conditions: Recurrence Free Survival
• Interventions: Drug: panitumumab (EGFR inhibitors)

• Registration Number: NCT06314997
• Lead Sponsor: Matteo's Friends

Brief 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).

Detailed Description

The investigators enroll patients with histologically confirmed advanced stage (T3 or T4, N1/2, M0/1) colorectal adenocarcinoma with molecular analysis on RAS mutant status. The participants are enrolled within 3 weeks at the time of progression disease (PD) from any line of therapy. Blood samples were collected from each participant after obtaining informed consent. Permission to perform CTCs analysis from blood was obtained from the Regional Ethical Committee (No.2013/34) and the study is conducted in accordance with the Declaration of Helsinki.

Study Timeline

• Study Start: 2019-01-14
• Study First Submitted: 2024-02-13
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-13
• Last Update Submitted: 2024-03-13
• Study First Posted: 2024-03-18
• Last Update Posted: 2024-03-18
• Primary Completion: 2024-12-17
• Study Completion: 2027-12-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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 Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CTCs	panitumumab (EGFR inhibitors)	-
RAS unmutated CTCs HER negative	panitumumab (EGFR inhibitors)	-
RAS unmutated CTCs HER positive	panitumumab (EGFR inhibitors)	-

Primary Outcome Measures

Name	Time	Method
The primary efficacy end point was recurrence- free survival at 12 months.	12 months

Trial Locations

Locations (1)

Natalia Malara; 🇮🇹 Germaneto, Italy