Clinical trial · Observational
COLON ERDERLY LOW DOSE
RETROSPECTIVE OBSERVATIONAL STUDY OF CHEMOTHERAPY IN ELDERLY PATIENTS IN THE FIRST-LINE TREATMENT OF METASTATIC COLORECTAL CANCER
NCT06840977CI-TRIAL-00118175CELOWrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Adenocarcinoma | Colon Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Retrospective
- description
- PATIENTS AGED 70 YEARS AND OVER IN FIRST-LINE TREATMENT OF METASTATIC COLORECTAL CANCER
Primary outcomes (2)
- measure
- Neutropenia incidence
- timeFrame
- 24 months
- description
- overall incidence of grade 4 neutropenia or febrile neutropenia of less than 8%
- measure
- Diarrehea incidence
- timeFrame
- 24 months
- description
- incidence of grade 3-4 diarrhea of less than 8%.
Secondary outcomes (4)
- measure
- PFS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (5)
- RESULTStueger 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
- RESULTTakashima 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
- RESULTLonardi 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
- RESULTCunningham 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
- RESULTYoshino 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.