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临床试验/NCT06840977
NCT06840977招募中不适用

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

Matteo Clavarezza3 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2026年7月7日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
51
试验地点
3
主要终点
Neutropenia incidence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
70 Years 至 99 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Retrospective

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

结局指标

主要结局

Neutropenia incidence

时间窗: 24 months

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

Diarrehea incidence

时间窗: 24 months

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

次要结局

  • 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)

研究者

发起方
Matteo Clavarezza
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Matteo Clavarezza

MD

Ente Ospedaliero Ospedali Galliera

研究点 (3)

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