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NCT Number: NCT06840977

COLON ERDERLY LOW DOSE

In this retrospective observational study, the case series of patients undergoing first-line treatment for metastatic colorectal adenocarcinoma with doublet fixed-dose and reduced-dose chemotherapy in combination with full-dose monoclonal antibody in patients aged 70 years or older is collected.

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Key information

Age range

70 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

E.O. Ospedali Galliera, Genova, GE, Italy

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About this study

Treatment in the elderly first-line patient of metastatic colorectal cancer is often conditioned by the age and general condition of the patient.

Such treatment involves the combination of chemotherapy and biological therapy targeted on the basis of the site and genetic mutations of the colorectal tumour, in particular RAS and BRAF.

With regard to targeted biologic therapy, the choice of monoclonal antibody is determined by tumour site and mutations. In particular, for right-sided and/or RAS/BRAF mutated tumours anti-VEGF therapy with Bevacizumab is the best option, whereas for left-sided and RAS/BRAF WT tumours monoclonal antibodies Panitumunab or Cetuximab are the choice.

In the elderly patient, the intensity of chemotherapy to be combined with targeted biologic therapy varies according to the patient's age, general condition and treatment goals. In particular for patients aged 70 years or older, a valid option is the combination of monochemotherapy with fluorodrugs in combination with bevacizumab. In addition, an Italian randomised trial tested monochemotherapy with 5-Fluorouracil in combination with Panitumumab in RAS WT/BRAF WT tumours and obtained the same efficacy as a doublet of chemotherapy with FOLFOX also in combination with Panitumumab.

Full-dose doublet chemotherapy is hardly feasible in the elderly patient because of the frailty of these patients and the high risk of toxicity.

In this retrospective observational study, we report on the case series of patients undergoing first-line treatment for metastatic colorectal adenocarcinoma with doublet of fixed-dose and reduced-dose chemotherapy in combination with full-dose monoclonal antibody in patients 70 years of age and older.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • G8 score ≥ 12
  • Patients with colorectal adenocarcinoma MSS
  • Patients with BRAF WT colorectal adenocarcinoma
  • Ability to understand and sign the informed consent form.

Exclusion criteria

  • Patients with MSI tumours
  • Patients with BRAF V600E mutated tumours
  • Patients not eligible for doublet chemotherapy by clinical decision

Treatment and study plan

Primary outcomes

  1. Neutropenia incidence

    Time frame: 24 months

    overall incidence of grade 4 neutropenia or febrile neutropenia of less than 8%

  2. Diarrehea incidence

    Time frame: 24 months

    incidence of grade 3-4 diarrhea of less than 8%.

Secondary outcomes

  1. PFS

    Time frame: 24 months

    Progression Free Survival (PFS), i.e. the time from day 1 of cycle 1 of treatment to the date of progression or death, whichever occurs first

  2. OS

    Time frame: 24 months

    Overall Survival (OS), which is the time between the date of cycle day 1 of treatment and death

  3. differences in toxicity of anti-VEGF monoclonal antibodies

    Time frame: 24 months

    Assess toxicity between in ANTI-VEGF monoclonal antibodies

  4. differences in toxicity of anti-EGFR monoclonal antibodies

    Time frame: 24 months

    Assess toxicity between in ANTI-EGFR monoclonal antibodies

Study contacts

Contact information is provided by the study sponsor or research team.

Davide S Corradengo

CONTACT

[email protected]

010.5634580 ext. +39

Matteo Clavarezza

CONTACT

[email protected]

010.5634580 ext. +39

Sponsors and collaborators

Lead sponsor

Matteo Clavarezza

Other

Registry information

Official study title

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

Acronym: CELOW

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 21, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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