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A multicenter study to explore the benefit of patient-reported outcome (PRO:ePRO/paper-PRO) monitoring in the treatment of patients with advanced renal cell carcinoma with cabozantinib.

Cabozantinib ePRO study

108

In this study, the full analysis set (FAS) was defined as the analysis set, and the primary analysis set for efficacy and safety analyses was defined as "FAS". "FAS" was defined as "randomized study subjects who received at least 1 dose of the study drug." The efficacy analysis included 36 subjects in the ePRO monitoring group, 37 subjects in the paper-PRO monitoring group, and 35 subjects in the Usual Care group. Of the assigned study subjects, 1 subject in the Usual Care group (After allocation, treatment was discontinued because adverse events occurred before administration of the study drug.) was excluded from the efficacy analysis. The mean age of the study subjects was 67.7 years in the ePRO monitoring group, 66.2 years in the paper-PRO monitoring group, and 68.1 years in the Usual Care group. The percentage of male subjects was 69.4% in the ePRO monitoring group, 81.1% in the paper-PRO monitoring group, and 85.7% in the Usual Care group. The proportion of male subjects was high in all groups, but the proportion of female subjects was slightly higher in the ePRO monitoring group than in the other groups.

Of 110 subjects who consented to the study, 1 subject was excluded because it was found that they did not meet the eligibility criteria. The remaining 109 subjects were assigned to 36 subjects in the ePRO monitoring group, 37 subjects in the paper-PRO monitoring group, and 36 subjects in the Usual Care group. In addition, 1 subject in the Usual Care group withdrew from the study because he/she discontinued the study before administration of the study drug after assignment.12 subjects in the ePRO monitoring group, 9 subjects in the paper-PRO monitoring group, and 15 subjects in the Usual Care group discontinued the study prematurely.

In the safety analysis set, TEAEs occurred in 100.0% of the ePRO monitoring group, 97.3% of the paper-PRO monitoring group, and 100.0% of the Usual Care group. TEAEs of Grade >= 3 occurred in 69.4% of the ePRO monitoring group, 45.9% of the paper-PRO monitoring group, and 42.9% of the Usual Care group. Serious TEAEs occurred in 27.8% of the ePRO monitoring group, 27.0% of the paper-PRO monitoring group, and 40.0% of the Usual Care group. TEAEs leading to discontinuation of the study drug occurred in 11.1% of the ePRO monitoring group, 5.4% of the paper-PRO monitoring group, and 8.6% of the Usual Care group. TEAEs leading to dose adjustment of the study drug (Dose reduction or withdrawal. Does not include discontinuation) occurred in 83.3% of the ePRO monitoring group, 91.9% of the paper-PRO monitoring group, and 88.6% of the Usual Care group. Among all TEAEs that occurred in this study, the SOC with the highest incidence was skin and subcutaneous tissue disorders , which occurred in 66.7% of the ePRO monitoring group (24 subjects), 86.5% of the paper-PRO monitoring group (32 subjects), and 71.4% of the Usual Care group (25 subjects). Gastrointestinal disorders were classified as follows: 69.4% (25 subjects) in the ePRO monitoring group, 64.9% (24 subjects) in the paper-PRO monitoring group, and 57.1% (20 subjects) in the Usual Care group; general and general disorders and administration site conditions were classified as follows: 44.4% (16 subjects) in the ePRO monitoring group, 54.1% (20 subjects) in the paper-PRO monitoring group, and 45.7% (16 subjects) in the Usual Care group; vascular disorders were classified as follows: 58.3% (21 subjects) in the ePRO monitoring group, 45.9% (17 subjects) in the paper-PRO monitoring group, and 37.1% (13 subjects) in the Usual Care group; metabolic and nutritional disorders were classified as follows: 36.1% (13 subjects) in the ePRO monitoring group, 29.7% (11 subjects) in the paper-PRO monitoring group, and 34.3% (12 subjects) in the Usual Care group; nervous system disorders were classified as follows: 36.1% (13 subjects) in the ePRO monitoring group, 40.5% (15 subjects) in the paper-PRO monitoring group, and 22.9% (8 subjects) in the Usual Care group, Respiratory, thoracic, and mediastinal disorders were 45.7% (9 subjects) in the ePRO monitoring group, 58.3% (20 subjects) in the paper-PRO monitoring group, and 45.9% (9 subjects) in the Usual Care group; laboratory tests were 37.1% (7 subjects) in the ePRO monitoring group, 36.1% (16 subjects) in the paper-PRO monitoring group, and 69.4% (21 subjects) in the Usual Care group; hepatobiliary disorders were 64.9% (17 subjects) in the ePRO monitoring group, 57.1% (9 subjects) in the paper-PRO monitoring group, and 44.4% (4 subjects) in the Usual Care group; endocrine disorders were 54.1% (8 subjects) in the ePRO monitoring group, 25.0% (9 subjects) in the paper-PRO monitoring group, and 37.8% (6 subjects) in the Usual Care group; and infections and parasitic diseases were 25.7% (5 subjects) in the ePRO monitoring group, 19.4% (2 subjects) in the paper-PRO monitoring group, and 29.7% (8 subjects) in the Usual Care group, In other cases, the incidence was <=69.4%.

The usefulness of ePRO/paper-PRO monitoring could not be clarified in this study. There were no new safety concerns compared with the safety information in the package insert.

This study investigated whether using PRO monitoring to manage adverse events in patients with advanced renal cell carcinoma treated with cabozantinib would prevent adverse events from worsening and result in changes in HRQOL. As a result, in comparing the rate of deterioration in the HRQOL index FKSI-19, the superiority of the ePRO group over the Usual Care group and the combined paper-PRO and Usual Care group was not observed.

Dec. 27, 2025

Yes

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

https://jrct.mhlw.go.jp/latest-detail/jRCTs011210055

Osawa Takahiro

Hokkaido University Hospital

N14W5 Kitaku, Sapporo city, Hokkaido

taka0573@gmail.com

Osawa Takahiro

Hokkaido University Hospital

N14W5 Kitaku, Sapporo city, Hokkaido

+81-11-716-1161

taka0573@gmail.com

Complete

Dec. 06, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1.Patients aged 18 years or older at the time of informed consent (regardless of gender)
2.Patients with clinically or histologically confirmed renal cell carcinoma who are deemed eligible for cabozantinib according to the package insert.
3.Patients who are receiving treatment including immune checkpoint inhibitors (Pembrolizumab,
ipilimumab, nivolumab, avelumab, etc.) for renal cell carcinoma.
4.Patients who are scheduled to start treatment with cabozantinib monotherapy for unresectable or metastatic renal cell carcinoma (treatment start dose:60mg/day)
5.Karnofsky Performance Status (KPS) score >= 60%
6.Patients capable of handling electronic devices (may require some assistance)
7.CT or MRI including the chest and abdomen has been assessed or is expected to be assessed within 28 days prior to initiation of cabozantinib treatment (Imaging is recommended as much as possible for both CT and MRI.)
8.Patients expected to survive for at least 6 months at the time of informed consent
9.In the opinion of the investigator or sub-investigator, the subject is capable of understanding and complying with protocol requirements.
10.Patients who can sign and date a written informed consent form prior to enrollment in the study

1.Patients with treatment-emergent adverse events that have not resolved to baseline or Grade <= 1 according to CTCAE version 5.0. unless clinically insignificant or stable on supportive care.
2.Pregnant or breastfeeding women, or women who are unable to prevent pregnancy during the study and for 4 months after the last dose.
3.Patients unable to swallow tablets
4.Patients previously treated with cabozantinib
5.History of allergy or hypersensitivity to any of the ingredients of cabozantinib.
6.Current or planned participation in another clinical study or a clinical study involving an intervention.
7.Other patients considered ineligible for the study by the investigator or sub-investigator

Both

Renal cell carcinoma

randomaization

Renal cell carcinoma

Deterioration rate of the Functional Assessment of Cancer Therapy (FACT) -Kidney Cancer Symptom Index (FKSI -19) during the period until Week 24 or discontinuation
Deterioration rate of FKSI: A decrease of >= 5 points from baseline is defined as deterioration, and the percentage of study subjects whose FKSI-19 assessment after the start of cabozantinib was reduced by at least one time from baseline by at least 5 points.

-Changes in FKSI-19
-Changes in Medical outcome study short form-8 (SF-8)
-Change in EQ-5D-5L
-Changes in instrumental activities of daily living (IADL)
-Progression free survival (PFS) assessed by the investigator or subinvestigator based on RECIST1. 1 and PFS rate at Week 24
-Dose adjustment (Interruption, dose reduction, discontinuation) rate and duration during the study
-relative dose intensity (RDI)
-Frequency of therapeutic interventions for TEAEs outside of scheduled visits
-Time analysis of period until FKSI-19 Progression
-Safety
-Percentage of Participants with Treatment-Emergent Adverse Events (TEAE) Following Cabozantinib Treatment
-Proportion of subjects with Grade 3 or higher TEAEs.
-Proportion of subjects with serious TEAEs.
-Percentage of study subjects who discontinued cabozantinib due to a TEAE
-Percentage of participants with TEAEs leading to dose modification (dose reduction or interruption) of cabozantinib
-Time to first awareness by the investigator of the occurrence of a TEAE
-Time to start handling TEAEs
-Questionnaire survey of investigators and study subjects (ePRO/paper-PRO monitoring group only)
-ePRO/paper-PRO adherence rates (ePRO/paper-PRO monitoring arm only)

+81-11-706-7934

Nov. 11, 2021

none