Randomized Study Evaluating the Impact of an Innovative and Cooperative Pathway Integrating Oncogeriatric, Pharmaceutical and Pharmacological Follow-up in Elderly Patients (>70 Years Old) Presenting With Cancer and Treated With Oral Therapy.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 794
- 试验地点
- 1
- 主要终点
- To assess the impact of reinforced multi-professional care pathway in geriatric oncology on the occurrence of grade ≥3 non-hematologic adverse event or grade ≥4 hematologic adverse event (according to NCI-CTCAE Version 6.0)
研究概览
简要总结
The incidence of cancer among older adults is increasing as a result of longer life expectancy. Therapeutic advances have led oncologists to propose new available treatments for these patients, particularly oral therapies, whether targeted therapies or hormone therapies. However, these patients are more vulnerable and have an increased risk of treatment-related toxicity or inefficacy. Indeed, they more frequently suffer from comorbidities (renal, cardiac, hepatic insufficiency, etc.) and present risk factors (polypharmacy, cognitive disorders, etc.) known to reduce the effectiveness or increase the toxicity of oral therapies due to variations in plasma drug concentrations.
For several years, various international recommendations (ASCO, ESMO, etc.) have suggested that specialized geriatatric oncology care is indicated for these patients. Similarly, some studies have shown that pharmacist involvement may have an impact by reducing drug-drug interaction issues or non-adherence. Finally, the introduction of oral therapies in oncology has raised pharmacological challenges: regular pharmacokinetic monitoring could allow dose adjustments in cases of disease progression in undertreated patients or toxicity in overexposed patients.
Our hypothesis is that implementing an integrative care pathway in this population could demonstrate a benefit by improving quality of care, reducing toxicity, optimizing efficacy, and maintaining an acceptable cost. This approach could help prevent early treatment discontinuation due to disease progression related to insufficient drug concentrations, as well as certain toxicities related to overdosing (e.g., drug-drug interactions), leading to improved quality of life and a reduction in rehospitalization rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Age ≥ 70 years old
- •G8 score ≤ 14
- •ECOG PS ≤ 3
- •Follow-up for a locally advanced or metastatic solid tumor among the following: breast, lung, prostate, colon, kidney, sarcoma, GIST cohorts
- •With a decision to initiate treatment with oral therapy (Tyrosine Kinase Inhibitor, Hormone Therapy, chemotherapy) from among the following:
- •Breast cohort: Abemaciclib, Ribociclib, Palbociclib, Everolimus
- •Lung cohort: Alectinib, Brigatinib, Osimertinib
- •Prostate cohort: Abiraterone, Enzalutamide, Olaparib
- •Colon Cohort: Trifluridine+Tipiracil, Capecitabine
- •Kidney cohort: Axitinib, Cabozantinib, Lenvatinib
- •Sarcoma/ GIST cohort: Sunitinib, Regorafenib, Pazopanib
- •Female patients must either be of non reproductive potential or must have a negative serum pregnancy test within 14 days prior to the administration of study drug. Childbearing potential women must have agreed to use one barrier method of contraception, such as condom, plus an additional highly effective method of contraception during treatment on this trial an for up to 6 month after the last dose of study treatment
- •Sexually active males patients must agree to use condom during the clinical investigation and for at least 6 months after the study treatment. Also, it is recommended the childbearing potential female partner uses a highly effective method of contraception for the same duration
- •Written, dated and signed informed consent by the patient prior to any specific protocol procedure
- •Ability to comply with the protocol procedures
- •Patients must be affiliated to a social security system or beneficiary of the same
排除标准
- •Patient who has already been treated or is currently being treated with the oral therapy studied
- •Grade 3 or 4 toxicity contraindicating the implementation of oral treatment, according to the NCI-CTCAE version 6.0
- •Patient unable to follow treatment program
- •Mental or psychological illness that does not allow the patient to give informed consent
- •Patient who has already benefited from specialized oncogeriatric care in the last 12 months
- •Patient who has already benefited from a pharmacological dosage for the oral therapy studied
- •Presence of a pathology or condition that makes the patient's participation in the study inappropriate which includes serious unresolved or unstable toxicities from previous administration of another investigational treatment or any medical condition that could interfere with patient safety, obtaining consent, or compliance with study procedures
- •Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
研究组 & 干预措施
Control arm
Initial oncogeriatric evaluation then standard follow-up according to the current practices of the center.
Interventional arm
Initial oncogeriatric evaluation then Oncogeriatric, pharmaceutical and pharmacological follow-up.
干预措施: Experimental (Other)
结局指标
主要结局
To assess the impact of reinforced multi-professional care pathway in geriatric oncology on the occurrence of grade ≥3 non-hematologic adverse event or grade ≥4 hematologic adverse event (according to NCI-CTCAE Version 6.0)
时间窗: over a maximum of 24 months after randomization
次要结局
- Number of adverse events (NCI-CTCAE Version 6.0)(over 24 months, after randomization)
- Overall Survival(over 24 months, after randomization)
- Progression-Free Survival(over 24 months, after randomization)
- Quality of life questionnaires(over 24 months, after randomization)