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Trial Title: Dynamic Changes in Circulating Tumour Cells Protein Expression

NCT ID: NCT06314997

Condition: Recurrence Free Survival

Conditions: Official terms:
Neoplastic Cells, Circulating
Recurrence
Panitumumab

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: Single (Participant)

Intervention:

Intervention type: Drug
Intervention name: panitumumab (EGFR inhibitors)
Description: 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
Arm group label: CTCs
Arm group label: RAS unmutated CTCs HER negative
Arm group label: RAS unmutated CTCs HER positive

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Natalia Malara

Address:
City: Germaneto
Zip: 88100
Country: Italy

Status: Recruiting

Start date: January 14, 2019

Completion date: December 18, 2027

Lead sponsor:
Agency: Matteo's Friends
Agency class: Other

Source: Matteo's Friends

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06314997

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