Clinical trial Recruiting at 1 site Observational Ages 70 to 99

Elderly patients with metastatic colorectal cancer: first-line reduced-dose chemo plus targeted antibody

Official title: RETROSPECTIVE OBSERVATIONAL STUDY OF CHEMOTHERAPY IN ELDERLY PATIENTS IN THE FIRST-LINE TREATMENT OF METASTATIC COLORECTAL CANCER

Run by Ente Ospedaliero Ospedali Galliera · NCT06840977 · Data updated 2026-11-12

This retrospective study looks at whether starting older patients (70+) on a reduced-dose doublet chemotherapy combined with a full-dose monoclonal antibody can be feasible in first-line treatment for metastatic colorectal cancer.

More Colon Adenocarcinoma trials

Quick facts

Study typeObservational
Ages70 Years to 99 Years
SexAll
Enrollment51 (estimated)
SponsorEnte Ospedaliero Ospedali Galliera
Academic / other
Drugs / interventionschemotherapy, Bevacizumab, Cetuximab, Panitumumab
Locations2 sites (Genova, GE and 1 other locations)
StatusRecruiting
StartedJuly 7, 2026
Main results expectedJune 30, 2027
Study endsJuly 31, 2027
Registry record updatedJuly 16, 2026
Trial IDNCT06840977 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients aged 70 or older with metastatic colorectal adenocarcinoma, MSS, BRAF WT, RAS wild-type status, good performance status (G8 score ≥ 12), and no MSI by current testing.

Probably not a fit

Patients with MSI or BRAF V600E mutations, or those not eligible for doublet chemotherapy due to clinical reasons, may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a retrospective observational analysis of first-line treatment patterns in patients aged 70 or older with metastatic colorectal adenocarcinoma. It describes the use of fixed or reduced-dose chemotherapy in combination with monoclonal antibody therapy, guided by tumor site and mutations (RAS/BRAF). The report discusses patient selection factors such as age, general condition, and G8 score that influence treatment intensity. The aim is to understand real-world practice and outcomes in a population for whom full-dose regimens often pose higher toxicity risk. Interventions and specific data collection methods are not prospectively defined in detail, as this is based on existing records.

Why it matters

Potential benefit: If successful, this approach could offer a tolerable first-line option for fit elderly patients, balancing effectiveness with reduced toxicity.

How similar studies have gone: Similar strategies with reduced-dose or monochemotherapy plus targeted antibodies have shown comparable efficacy in selected elderly populations in prior trials.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. 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.
2. Age ≥ 70 years
3. G8 score ≥ 12
4. Patients with colorectal adenocarcinoma MSS
5. Patients with BRAF WT colorectal adenocarcinoma
6. Ability to understand and sign the informed consent form.

Exclusion Criteria:

1. Patients with MSI tumours
2. Patients with BRAF V600E mutated tumours
3. Patients not eligible for doublet chemotherapy by clinical decision

Where it's running

  • E.O. Ospedali Galliera
    Genova, Ge, Italy
    Recruiting
  • E.O. Ospedali Galliera
    Genoa, Liguria, Italy
    Not yet recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.