UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective evaluation of the factors in geriatric assessment for predicting the vulnerability of the elderly patients in out-patient chemotherapy
Title of the study (Brief title)	Prospective evaluation of the factors in geriatric assessment for predicting the vulnerability of the elderly patients in out-patient chemotherapy
Region	Japan

Condition
Condition	Elderly cancer patients with solid tumors
Classification by specialty	Medicine in general Hematology and clinical oncology Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To prospectively investigate which tools for ADL assessent (MOS-ADL, KPS, G8, or VES-13) could best predict the tolerability of the out-patient chemotherapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	To investigate which tools for ADL assessent (MOS-ADL, KPS, G8, or VES-13) could best predict the tolerability of the out-patient chemotherapy
Key secondary outcomes	To investigate the tolerability of the chemotherapy regimens selected by physician's subjective evaluation and CGA components independently associated with the tolerability.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) with 70 years of age or older (2) with a histologically confirmed diagnosis of cancer at any stage (3) those planing to continue chemotherapy more than 3 months (4) those fluent in Japanese
Key exclusion criteria	(1) with disturbance of consciousness (2) with severe physical impairment (3) with severe mental disorder (4) with hematologic malignancy (4) those considered inappropriate for the participation
Target sample size	100

Research contact person
Name of lead principal investigator	Yuichi Ando
Organization	Nagoya University Hospital
Division name	Clinical Oncology and Chemotherapy
Address	65 Tsuruma, Showa-ku, Nagoya, Japan
TEL	052-741-1903
Email	yando@med.nagoya-u.ac.jp

Public contact
Name of contact person	Ayumu Matsuoka
Organization	Nagoya University Hospital
Division name	Clinical Oncology and Chemotherapy
Address	65 Tsuruma, Showa-ku, Nagoya, Japan
TEL	052-741-1903
Homepage URL
Email	ayumu0611@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

Funding Source
Organization	Management Expenses Grants
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	2016 Year 11 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	(1) Completion of cancer-specific geriatric assessment before the initiation of the out-patient chemotherapy (2) Measurement of MOS-ADL, KPS, G8, VES-13 and grip strength every month

Management information
Registered date	2016 Year 10 Month 13 Day
Last modified on	2016 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028080