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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042447
Receipt No. R000048457
Scientific Title Multicenter, Open-label, Randomized Comparative Study to Verify the Usefulness of Monitoring of Electronic Patient Reported Outcome (ePRO) in Patients with Unresectable Advanced Cancers and Metastasized or Relapsed Solid Tumors
Date of disclosure of the study information 2020/11/13
Last modified on 2020/11/13

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Basic information
Public title Multicenter, Open-label, Randomized Comparative Study to Verify the Usefulness of Monitoring of Electronic Patient Reported Outcome (ePRO) in Patients with Unresectable Advanced Cancers and Metastasized or Relapsed Solid Tumors
Acronym PRO-MOTE
Scientific Title Multicenter, Open-label, Randomized Comparative Study to Verify the Usefulness of Monitoring of Electronic Patient Reported Outcome (ePRO) in Patients with Unresectable Advanced Cancers and Metastasized or Relapsed Solid Tumors
Scientific Title:Acronym PRO-MOTE
Region
Japan

Condition
Condition Unresectable Advanced Cancers and Metastasized or Relapsed Solid Tumors(Breast cancer, lung cancer, stomach cancer, colon cancer, squamous cell carcinoma of the head and neck, liver cancer, endometrial cancer, ovarian cancer)
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology Breast surgery Obsterics and gynecology
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify the hypothesis that adding ePRO monitoring to standard care is useful for prolonging OS or maintaining or improving HRQoL in patients with unresectable advanced cancers and metastasized or relapsed solid tumors who are receiving systemic pharmacotherapy.
Basic objectives2 Others
Basic objectives -Others Verify
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) OS
(2) HRQoL
The global health status score on the The European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30) at all measurement time points to Week 24 after enrollment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 [Monitoring arm]
ePRO monitoring will be conducted once weekly after study enrollment. The monitoring will concern treatment of each predefined type of cancer or characteristic symptoms of the condition. PRO-CTCAE (Patient-Reported Outcome-Common Terminology Criteria for Adverse Events) will be used as the scale for monitoring symptoms. The patient and (sub)investigator will share the monitoring results during examinations and use them to determine treatment strategies, etc. Threshold values will be predefined for a diagnosis of "severe" for individual symptoms. When it is reported that a threshold value has been exceeded, an alert notification will be sent to the study staff member assigned to the patient. The (sub)investigator who receives the notification will assess the information in the notification and take the best course of action.
Interventions/Control_2 [Control arm]
Standard care will be given.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria (1) Unresectable, advanced, metastasized, or relapsed solid tumors
(2) Expected to be able to undergo treatment or observation for at least 6 months at the study site
(3) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
(4) Receiving systemic anticancer mono- or combination pharmacotherapy (e.g., cytotoxic anticancer agents, molecularly targeted drugs, and immune checkpoint inhibitors) at enrollment or scheduled to begin such therapy within 1 month from the date of enrollment
(In principle, patients should be receiving pharmacotherapy on an out-patient basis.)
(5) Capable of using electronic device (includes cases needing some assistance)
(6) Aged >=20 to <80 years at informed consent
(7) Written consent for the study personally obtained from the subject
Key exclusion criteria (1) Has undergone four or more regimens of pharmacotherapy for advanced, metastasized, or relapsed solid tumors*Notes 1, 2
(2) Currently participating in a study where PRO is tracked and the results are passed on to a physician
(3) The following are exclusion criteria for individual types of cancer
1) Breast cancer
- Scheduled to receive or currently receiving endocrine therapy (including endocrine therapy in combination with other agents) for hormone receptor-positive breast cancer
- Scheduled to receive or currently receiving first regimen of anti-HER2 therapy for HER2-positive disease
2) Liver cancer
- Hepatic function of Child-Pugh B/C
(4) Deemed otherwise unsuitable for the study by the investigator or sub-investigator
*Notes:
1. If the disease has relapsed during perioperative adjuvant chemotherapy or within 24 weeks after adjuvant chemotherapy, the adjuvant chemotherapy will be considered as the first regimen of adjuvant chemotherapy.
2. Does not include endocrine therapy for breast cancer.
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Hironobu
Middle name
Last name Minami
Organization Kobe University Graduate School
Division name Oncology and Hematology, Internal Medicine Program, Medical Research Division
Zip code 650-0017
Address 7-5-1, Kusunokicho, Chuo-ku, Kobe City, Hyogo Prefecture
TEL 078-382-5820
Email hminami@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Akira
Middle name
Last name Yamao
Organization Public Health Research Foundation
Division name Office of Comprehensive Support Project for Oncology Research (CSPOR)
Zip code 169-0051
Address 1-1-7 Nishiwaseda, Shinjuku-ku, Tokyo
TEL 03-5287-2636
Homepage URL
Email csp-qol@csp.or.jp

Sponsor
Institute Public Health Research Foundation
Institute
Department

Funding Source
Organization National Institute of Public Health
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kobe university hospital clinical and translational research center
Address 7-5-1, Kusunokicho, Chuo-ku, Kobe City, Hyogo Prefecture
Tel 078-382-6669
Email kainyu@med.kobe-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 13 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2010 Year 11 Month 13 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 21 Day
Last follow-up date
2025 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 13 Day
Last modified on
2020 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048457

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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