2025-523610-83-00招募中4 期
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 _ POG
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 794
- 试验地点
- 16
- 主要终点
- Rate of subjects who had at least one grade ≥3 non-hematologic or grade ≥4 hematologic adverse event assessed during oncologist consultations according to the National Cancer Institute Common Toxicity Scale Criteria for Adverse Events Version 6.0 (NCI-CTCAE Version 6.0) on the duration of treatment with oral anticancer drug started at inclusion. The adverse events will be collected at M1, M3 then every 3 months.
研究概览
简要总结
To assess the impact of reinforced multi-professional care pathway (oncologist, geriatrician, pharmacist, pharmacologist) 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) over a maximum of 24 months in patients aged of at least 70 years and starting an oral anticancer treatment compared to usual care.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70 years old
- •Patients must be affiliated to a social security system or beneficiary of the same
- •G8 score ≤14
- •Follow-up for a locally advanced or metastatic solid tumor among the following: • Breast Cohort • Lung Cohort • Prostate cohort • Colon Cohort • Kidney Cohort • Sarcoma/GIST cohort
- •With a decision to initiate treatment with oral therapy (Tyrosine Kinase Inhibitor, Hormone Therapy) 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 (cf. paragraph 7.8 « Pregnancy and contraception »)
- •Written, dated and signed informed consent by the patient prior to any specific protocol procedure
- •Ability to comply with the protocol procedures
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 the therapeutic 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 the 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
结局指标
主要结局
Rate of subjects who had at least one grade ≥3 non-hematologic or grade ≥4 hematologic adverse event assessed during oncologist consultations according to the National Cancer Institute Common Toxicity Scale Criteria for Adverse Events Version 6.0 (NCI-CTCAE Version 6.0) on the duration of treatment with oral anticancer drug started at inclusion. The adverse events will be collected at M1, M3 then every 3 months.
Rate of subjects who had at least one grade ≥3 non-hematologic or grade ≥4 hematologic adverse event assessed during oncologist consultations according to the National Cancer Institute Common Toxicity Scale Criteria for Adverse Events Version 6.0 (NCI-CTCAE Version 6.0) on the duration of treatment with oral anticancer drug started at inclusion. The adverse events will be collected at M1, M3 then every 3 months.
次要结局
- For all patients : •Number of adverse events •Averall survival • Progression-free survival •Time to discontinuation of oral anticancer treatment • Rate of subjects having had at least one hospitalization in the 24 months following inclusion.• The incremental net monetary benefit (INMB) and incremental cost-effectiveness ratio (ICER) (cost-effectiveness analysis).• Quality of life questionnaires (EORTC QLQ-C30 and EuroQol EQ5D-5L questionnaires) at baseline (M0), M1, M3, M6, M12 and M24
- For patients in the interventional arm: • The average number of pharmaceutical interventions performed for the oncologist and the general practitioner • The proportion of patients with at least one potentially inappropriate drug prescription before and 3 months after pharmaceutical maintenance• The average number of medications prescribed per patient before and after the pharmaceutical interview • The complexity of the drug prescription assessed according to the MRCI score before and after
研究者
Dr. Arnaud BAYLE
Scientific
Institut Gustave Roussy
研究点 (16)
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