Impact of Geriatrician-implemented Interventions on Chemotherapy Delivery in Vulnerable Elderly Patients With Early or Metastatic Solid Malignancies: the GIVE Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 233
- 试验地点
- 6
- 主要终点
- Relative dose intensity
研究概览
简要总结
This is a randomized parallel group trial designed to evaluate the impact of implementing geriatrician-prescribed interventions based on the comprehensive geriatric assessment (CGA), on the ability to deliver adequate chemotherapy treatment, as measured by relative dose intensity (RDI).
详细描述
This randomized parallel group trial is designed to evaluate the impact of implementing geriatrician-prescribed interventions, on the ability to deliver adequate chemotherapy treatment, as measured by RDI of at least 85%, in a cohort of vulnerable [≥1 deficit identified at CGA and/or ≥1 comorbidity Grade 3-4 as defined by Cumulative Illness Rating Scale for Geriatrics (CIRS-G)] elderly cancer patients with early stage or advanced solid organ malignancies.
Patients will be randomized using a 2:1 allocation to Arm A: routine oncological care plus geriatric intervention or Arm B: routine oncological care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any solid tumors
- •Either early stage disease planned for treatment with neo/adjuvant chemotherapy, or metastatic disease planned for treatment with chemotherapy and ≤ 1 previous chemotherapy treatment in the metastatic setting
- •Absence of symptomatic central nervous system (CNS) metastases
- •Eastern Cooperative Oncology group (ECOG) performance status 0-2
- •Estimated life expectancy of ≥ 12 weeks
- •At least 1 deficit identified on CGA at screening/baseline, and/or at least one comorbidity of grade 3 or 4 severity, as defined by CIRS-G
- •Written informed consent in according to International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use/Good Clinical Practice (ICH/GCP), and national/local ethics regulations
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol and follow-up schedule
排除标准
- •Age ≤ 69 years
- •Any patients who did not meet the inclusion criteria
结局指标
主要结局
Relative dose intensity
时间窗: 6 months
Relative dose intensity (RDI) is defined as the ratio (in percentage) of the total administered dose of chemotherapy to the standard dose of the same chemotherapy regimen, as defined by the treating centre. RDI will be calculated as the total dose delivered from the first day of cycle 1 of chemotherapy until completion of the planned chemotherapy (average of 6 months for early, 3 months for metastatic disease), or until date of relapse or death or discontinuation from any cause, whichever occurs first.
次要结局
- Occurrence of treatment-related toxicity(every 3-4 weeks up to 6 months)
- Occurrence of hospitalization(at 6 months for early and at 3 months for metastatic disease)
- Early mortality(death from any cause occurring 12 months of randomization for neo/adjuvant patients, or within 6 months for patients with metastatic disease)
研究者
Laura Biganzoli
MD
Azienda USL 4 Prato