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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 70 Years to 99 Years |
| Sex | All |
| Enrollment | 51 (estimated) |
| Sponsor | Ente Ospedaliero Ospedali Galliera Academic / other |
| Drugs / interventions | chemotherapy, Bevacizumab, Cetuximab, Panitumumab |
| Locations | 2 sites (Genova, GE and 1 other locations) |
| Status | Recruiting |
| Started | July 7, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | July 16, 2026 |
| Trial ID | NCT06840977 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
- Principal investigator: Matteo Clavarezza — E.O. Ospedali Galliera
- Study coordinator: Matteo Clavarezza
- Email: matteo.clavarezza@galliera.it
- Phone: 010.5634580
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Postoperative ctDNA Monitoring to Predict Recurrence in Driver-Mutant Stage I-III Colon Cancer
This study tests whether checking blood tumor DNA after surgery can predict if driver-mutant stage I-III colon cancer will come back.
-
Adding tolecizumab to chemoimmunotherapy before surgery for locally advanced pMMR/MSS colon cancer
We're testing whether adding tolecizumab (a PCSK9 blocker) to sintilimab plus CapeOX before surgery helps people with pMMR/MSS locally advanced colon cancer (cT3c or higher) achieve a complete tumor response.
-
Family genetics: who shares test results with relatives
This study tests whether letting patients share genetic results with their relatives is as good as doctors sharing the results to help first-degree relatives get genetic testing for hereditary cancer risk.
-
Calderasib plus cetuximab and chemotherapy for KRAS G12C colorectal cancer
This trial will test whether adding calderasib and cetuximab to mFOLFOX6 helps people with unresectable locally advanced or metastatic colorectal cancer that has a KRAS G12C mutation live longer without their cancer growing.
-
Testing a new stool test for colorectal cancer detection
This study is testing a new stool test to see if it can help find colorectal cancer and advanced growths in people aged 45 and older who are at average risk.
-
Using HDAC inhibitors with chemoimmunotherapy for advanced colon cancer treatment
This study is testing if adding HDAC inhibitors to chemotherapy and immunotherapy can help people with advanced colon cancer have better treatment results and improve their chances of recovery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.