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Recruiting NCT06314997

Dynamic Changes in Circulating Tumour Cells Protein Expression

Phase II Interventional Objective Responsive Rate (ORR)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: panitumumab (EGFR inhibitors).
Who it may be relevant to
Registry conditions: Objective Responsive Rate (ORR). Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug panitumumab (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

Primary outcome measures

  • The primary efficacy end point was Objective Responsive Rate (ORR) at 12 months. [Time frame: 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Natalia Malara — Germaneto

Publications

  • Malara N, Donato G, Ferrazzo F, Garo NC, Fulciniti F. The Charactex Protocol for Blood-Derived Cytological Preparation of Nonhematological Cancer. Acta Cytol. 2023;67(3):295-303. doi: 10.1159/000527904. Epub 2022 Dec 12. PMID 36509041
  • Malara N, Coluccio ML, Grillo F, Ferrazzo T, Garo NC, Donato G, Lavecchia A, Fulciniti F, Sapino A, Cascardi E, Pellegrini A, Foxi P, Furlanello C, Negri G, Fadda G, Capitanio A, Pullano S, Garo VM, Ferrazzo F, Lowe A, Torsello A, Candeloro P, Gentile F. Multicancer screening test based on the detection of circulating non haematological proliferating atypical cells. Mol Cancer. 2024 Feb 13;23(1):3 PMID 38350884
  • Malara N, Trunzo V, Foresta U, Amodio N, De Vitis S, Roveda L, Fava M, Coluccio M, Macri R, Di Vito A, Costa N, Mignogna C, Britti D, Palma E, Mollace V. Ex-vivo characterization of circulating colon cancer cells distinguished in stem and differentiated subset provides useful biomarker for personalized metastatic risk assessment. J Transl Med. 2016 May 12;14(1):133. doi: 10.1186/s12967-016-0876-y. PMID 27176720

Identifiers

NCT: NCT06314997 · 2013.34

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗