NCT06314997

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
20mo left

Started Jan 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jan 2019Dec 2027

Study Start

First participant enrolled

January 14, 2019

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2027

Expected
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

5.9 years

First QC Date

February 13, 2024

Last Update Submit

March 13, 2024

Conditions

Recurrence Free Survival

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy end point was recurrence- free survival at 12 months.

    12 months

Study Arms (3)

RAS unmutated CTCs HER positive

EXPERIMENTAL
Drug: panitumumab (EGFR inhibitors)

CTCs

EXPERIMENTAL
Drug: panitumumab (EGFR inhibitors)

RAS unmutated CTCs HER negative

EXPERIMENTAL
Drug: panitumumab (EGFR inhibitors)

Interventions

panitumumab (EGFR inhibitors)DRUG

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

CTCsRAS unmutated CTCs HER negativeRAS unmutated CTCs HER positive

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Natalia Malara

Germaneto, 88100, Italy

RECRUITING

Related Publications (3)

  • 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: 36509041BACKGROUND

  • 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):32. doi: 10.1186/s12943-024-01951-x.

    PMID: 38350884BACKGROUND

  • 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: 27176720BACKGROUND

MeSH Terms

Interventions

Panitumumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Natalia Malara, prof

CONTACT

03489705145nataliamalara@unicz.it

Natalia Malara

CONTACT

nataliamalara@unicz.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2024

First Posted

March 18, 2024

Study Start

January 14, 2019

Primary Completion

December 17, 2024

Study Completion (Estimated)

December 18, 2027

Last Updated

March 18, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)