Blood-based biomarker-driven therapy for advanced colorectal cancer
Dynamic Changes in RAS Gene Status and HER2 Expression in Circulating Tumour Cells: a Phase II Trial
PHASE2 · Matteo's Friends · NCT06314997
This study is testing whether a blood-based treatment using panitumumab can help people with advanced colorectal cancer live longer without their cancer coming back.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Matteo's Friends (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Germaneto) |
| Trial ID | NCT06314997 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, controlled trial investigates the efficacy of blood-based biomarker-driven therapy in patients with advanced stage colorectal adenocarcinoma. Participants are selected based on circulating tumor cells (CTCs) results and are assigned to treatment groups using block randomization. The study focuses on patients with specific tumor stages (T3 or T4) and RAS mutant status, collecting blood samples for analysis after informed consent. The intervention involves the use of panitumumab, an EGFR inhibitor, to assess its impact on recurrence-free survival.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced stage colorectal adenocarcinoma (T3 or T4) who have a confirmed RAS mutation and are medically able to receive chemotherapy.
Not a fit: Patients with evidence of infectious disease, a history of another primary cancer within the last three years, or synchronous primary colorectal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment options for patients with advanced colorectal cancer.
How similar studies have performed: Other studies utilizing blood-based biomarkers for targeted therapy have shown promise, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Germaneto
- Natalia Malara — Germaneto, Italy (RECRUITING)
Study contacts
- Study coordinator: Natalia Malara, prof
- Email: nataliamalara@unicz.it
- Phone: 03489705145
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Recurrence Free Survival