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AzTrials

Colon AdenocarcinomaCELOWNCT06840977

COLON ERDERLY LOW DOSE

An observational study of Colon Adenocarcinoma, run by Matteo Clavarezza at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 70 to 99 years
Conditions the study is for
Colon Adenocarcinoma
How many people
51 participants
Where
2 sitesItaly
Study dates
7 Jul 2026to 31 Jul 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 to 99 years
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: The study population includes patients aged 70 years and older, with metastatic colorectal adenocarcinoma, MSS, BRAF WT, with a G8 score greater than or equal to 12, candidates for metastatic first-line treatment

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Matteo Clavarezza contact

010.5634580 ext. +39

matteo.clavarezza@galliera.it

Davide S Corradengo contact

010.5634580 ext. +39

davide.corradengo@galliera.it

Italy2 sites, 2 recruiting

  • E.O. Ospedali Galliera

    Genoa, Liguria, 16128

    Davide S Corradengo, 010.5634580 ext. +39, davide.corradengo@galliera.it

    Matteo Clavarezza

    Not yet recruiting

  • E.O. Ospedali Galliera

    Genova, GE, 16128

    Davide CORRADENGO, +390105634580, davide.corradengo@galliera.it

    Matteo Clavarezza, MD

    Recruiting

Other trials in Italy

About this study

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

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.

Read the detailed description

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.

Keywords
metastatic colorectal adenocarcinom, low doses, chemotherapy, monoclonal antibodies
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06840977
Study groupRoleWhat they receive
RetrospectivePATIENTS AGED 70 YEARS AND OVER IN FIRST-LINE TREATMENT OF METASTATIC COLORECTAL CANCER

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neutropenia incidence

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

    Measured: 24 months

  2. Diarrehea incidence

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

    Measured: 24 months

Secondary outcomes (4)

  1. PFS

    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

    Measured: 24 months

  2. OS

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

    Measured: 24 months

  3. differences in toxicity of anti-VEGF monoclonal antibodies

    Assess toxicity between in ANTI-VEGF monoclonal antibodies

    Measured: 24 months

  4. differences in toxicity of anti-EGFR monoclonal antibodies

    Assess toxicity between in ANTI-EGFR monoclonal antibodies

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2025
  2. Study start7 Jul 2026
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06840977
Sponsor's protocol ID
CELOW
Acronym
CELOW
Status last verified
Jul 2026
First submitted
18 Feb 2025
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stueger A, Joerger M, De Nys K. Geriatric evaluation methods in oncology and their use in clinical studies: A systematic literature review. J Geriatr Oncol. 2024 Apr;15(3):101684. doi: 10.1016/j.jgo.2023.101684. Epub 2023 Dec 9.

    PubMed 38072709

  • Takashima A, Hamaguchi T, Mizusawa J, Nagashima F, Ando M, Ojima H, Denda T, Watanabe J, Shinozaki K, Baba H, Asayama M, Hasegawa S, Masuishi T, Nakata K, Tsukamoto S, Katayama H, Nakamura K, Fukuda H, Kanemitsu Y, Shimada Y; Colorectal Cancer Study Group in Japan Clinical Oncology Group (JCOG). 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). J Clin Oncol. 2024 Nov 20;42(33):3967-3976. doi: 10.1200/JCO.23.02722. Epub 2024 Aug 26.

    PubMed 39186709

  • Lonardi S, Rasola C, Lobefaro R, Rossini D, Formica V, Scartozzi M, Frassineti GL, Boscolo G, Cinieri S, Di Donato S, Pella N, Bergamo F, Raimondi A, Arnoldi E, Antonuzzo L, Granetto C, Zustovich F, Ronzoni M, Leo S, Morano F, Loupakis F, Buggin F, Zagonel V, Fassan M, Cremolini C, Boni L, Pietrantonio F; GONO Foundation Investigators. 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. J Clin Oncol. 2023 Dec 1;41(34):5263-5273. doi: 10.1200/JCO.23.00506. Epub 2023 Aug 3.

    PubMed 37535876

  • Cunningham D, Lang I, Marcuello E, Lorusso V, Ocvirk J, Shin DB, Jonker D, Osborne S, Andre N, Waterkamp D, Saunders MP; AVEX study investigators. Bevacizumab plus capecitabine versus capecitabine alone in elderly patients with previously untreated metastatic colorectal cancer (AVEX): an open-label, randomised phase 3 trial. Lancet Oncol. 2013 Oct;14(11):1077-1085. doi: 10.1016/S1470-2045(13)70154-2. Epub 2013 Sep 10.

    PubMed 24028813

  • Yoshino T, Cervantes A, Bando H, Martinelli E, Oki E, Xu RH, Mulansari NA, Govind Babu K, Lee MA, Tan CK, Cornelio G, Chong DQ, Chen LT, Tanasanvimon S, Prasongsook N, Yeh KH, Chua C, Sacdalan MD, Sow Jenson WJ, Kim ST, Chacko RT, Syaiful RA, Zhang SZ, Curigliano G, Mishima S, Nakamura Y, Ebi H, Sunakawa Y, Takahashi M, Baba E, Peters S, Ishioka C, Pentheroudakis G. Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with metastatic colorectal cancer. ESMO Open. 2023 Jun;8(3):101558. doi: 10.1016/j.esmoop.2023.101558. Epub 2023 May 24.

    PubMed 37236086

Questions about this trial

What is this clinical trial studying?

An observational study of Colon Adenocarcinoma, run by Matteo Clavarezza at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Matteo Clavarezza (010.5634580 ext. +39, matteo.clavarezza@galliera.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neutropenia incidence (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06840977, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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