Retrospective Study of First-Line Chemotherapy with Monoclonal Antibodies in Patients 70 to 99 Years Old with Metastatic Colorectal Adenocarcinoma
Led by Matteo Clavarezza · Updated on 2026-07-16
51
Participants Needed
2
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to observe treatments in patients aged 70 years or older who have metastatic colorectal adenocarcinoma and are receiving first-line therapy. It focuses on how chemotherapy combined with monoclonal antibodies is used in elderly patients, considering their age, general health, and tumour characteristics such as genetic mutations in RAS and BRAF. The study specifically collects data on patients treated with fixed-dose or reduced-dose chemotherapy doublets paired with full-dose monoclonal antibodies.
Treatment strategies vary based on tumour site and mutations, with anti-VEGF therapy using Bevacizumab preferred for right-sided or mutated tumours and anti-EGFR antibodies like Panitumumab or Cetuximab for left-sided wild-type tumours. Due to frailty and risk of toxicity, full-dose doublet chemotherapy is often not feasible in elderly patients, so reduced doses or monochemotherapy combined with monoclonal antibodies are commonly used. This study retrospectively gathers case series data on these treatment approaches in patients aged 70 and older.
Participants medical records are reviewed to assess outcomes such as neutropenia and diarrhea incidence over 24 months, along with progression-free survival and overall survival. Researchers also examine differences in toxicity between anti-VEGF and anti-EGFR monoclonal antibodies. The study collects information on patient condition, treatment type, and effectiveness markers during routine care without additional interventions, covering up to two years of follow-up.
CONDITIONS
Brief Title
COLON ERDERLY LOW DOSE
Research Team
M
Matteo Clavarezza
D
Davide S Corradengo
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Patients with metastatic colorectal adenocarcinoma not treated with any therapy in the metastatic phase. Previous (neo)-adjuvant treatment with fluoroderivatives with or without Oxaliplatin is permitted.
Age 70 years or older
G8 score 12 or higher
Patients with colorectal adenocarcinoma microsatellite stable (MSS)
Patients with BRAF wild-type colorectal adenocarcinoma
Ability to understand and sign the informed consent form.
You will not qualify if you...
Patients with microsatellite instability (MSI) tumours
Patients with BRAF V600E mutated tumours
Patients not eligible for doublet chemotherapy by clinical decision
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Monitoring
Duration - Up to 24 months
Participants' medical records and treatment outcomes are reviewed retrospectively to collect information on chemotherapy and monoclonal antibody use, side effects, and survival.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Oxaliplatin Added to Fluoropyrimidine/Bevacizumab as Initial Therapy for Unresectable Metastatic Colorectal Cancer in Older Patients: A Multicenter, Randomized, Open-Label Phase III Trial (JCOG1018).
Initial Panitumumab Plus Fluorouracil, Leucovorin, and Oxaliplatin or Plus Fluorouracil and Leucovorin in Elderly Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer: The PANDA Trial by the GONO Foundation.
Bevacizumab plus capecitabine versus capecitabine alone in elderly patients with previously untreated metastatic colorectal cancer (AVEX): an open-label, randomised phase 3 trial.
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