COLON ERDERLY LOW DOSE

NCT06840977 | Not Yet Recruiting DMC

• 1 other identifier: CELOW
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colon Adenocarcinoma

Keywords

metastatic colorectal adenocarcinom; low doses; chemotherapy; monoclonal antibodies

Outcome Measures

Primary Outcomes (2)

• Neutropenia incidence

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

  24 months

• Diarrehea incidence

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

  24 months

Secondary Outcomes (4)

• PFS

  24 months

• OS

  24 months

• differences in toxicity of anti-VEGF monoclonal antibodies

  24 months

• differences in toxicity of anti-EGFR monoclonal antibodies

  24 months

Study Arms (1)

Retrospective

PATIENTS AGED 70 YEARS AND OVER IN FIRST-LINE TREATMENT OF METASTATIC COLORECTAL CANCER

Eligibility Criteria

• Age: 70 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Matteo Clavarezza: lead

Study Sites (1)

E.O. Ospedali Galliera

Genoa, Liguria, 16128, Italy

Location

Related Publications (5)

• 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.

  PMID: 38072709 RESULT

• 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.

  PMID: 39186709 RESULT

• 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.

  PMID: 37535876 RESULT

• 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.

  PMID: 24028813 RESULT

• 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.

  PMID: 37236086 RESULT

Related Links

• CTCAE criteria v5

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Matteo Clavarezza

  E.O. Ospedali Galliera

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Clavarezza

CONTACT

010.5634580; matteo.clavarezza@galliera.it

Davide S Corradengo

CONTACT

010.5634580; davide.corradengo@galliera.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 21, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)