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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