Study Results
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Basic Information
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NOT_YET_RECRUITING
51 participants
OBSERVATIONAL
2026-02-01
2026-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Retrospective
PATIENTS AGED 70 YEARS AND OVER IN FIRST-LINE TREATMENT OF METASTATIC COLORECTAL CANCER
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
2. Patients with BRAF V600E mutated tumours
3. Patients not eligible for doublet chemotherapy by clinical decision
70 Years
99 Years
ALL
No
Sponsors
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Matteo Clavarezza
OTHER
Responsible Party
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Matteo Clavarezza
MD
Principal Investigators
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Matteo Clavarezza
Role: PRINCIPAL_INVESTIGATOR
E.O. Ospedali Galliera
Locations
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E.O. Ospedali Galliera
Genoa, Liguria, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Related Links
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Other Identifiers
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CELOW
Identifier Type: -
Identifier Source: org_study_id
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