UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Predicting chemotherapy toxicity in elderly patients with non small cell lung cancer
Title of the study (Brief title)	Predicting elderly patients' vulnerability for chemotherapy
Region	Japan

Condition
Condition	non small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The goals of this study are to identify risk factors for chemotherapy toxicity in elderly patients and develop a risk stratification schema for chemotherapy toxicity.
Basic objectives2	Others
Basic objectives -Others	We want to develop a risk stratification schema for chemotherapy toxicity, and predict chemotherapy toxicity in elderly patients.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Assessment for elderly patients; vulnerability for chemotherapy and incidence of toxicity
Key secondary outcomes	Assessment for compliance of chemotherapy, response rate and overall survival

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	Eligibility criteria are as follows: (1) pathologically proven non-small cell lung cancer adaptable to chemotherapy; (2)chemotherapy naive patients inadequate for operation and radiation therapy; (3) patients with aged 70 and over; (4) written informed consent.
Key exclusion criteria	Exclusin criteria are as follows: (1) patients with active other cancers; (2) patients treated with chemotherapy; (3)patients who needs thoracic radiotherapy; (4) patients who have pleural effusion with poor control; (5) Unsuitable cases are whom doctors jugde unable to be carried out this research safely, and who have severe dementia.
Target sample size	350

Research contact person
Name of lead principal investigator	Masaki Kanazu
Organization	National Hospital Organization Toneyama Hospital
Division name	Department of Internal Medicine
Address	5-1-1, toneyama, Toyonaka, Japan
TEL	06-6853-2001
Email	kanamasa@toneyama.go.jp

Public contact
Name of contact person	Masaki Kanazu
Organization	National Hospital Organization Toneyama Hospital
Division name	Department of Internal Medicine
Address	5-1-1, toneyama, Toyonaka, Japan
TEL	06-6853-2001
Homepage URL
Email	kanamasa@toneyama.go.jp

Sponsor
Institute	National Hospital Organization Kinki-chuo Chest Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Kinki-chuo Chest Medical Center
Organization
Division
Category of Funding Organization	Other
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	2013 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 27 Day
Anticipated trial start date	2013 Year 04 Month 03 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	Patients' characteristics, symptoms, clinical laboratory data, and activities of daily living are assessd at enrollment of study. Then, symptoms, clinical laboratory data, and clinical course are observed during medical treatments.

Management information
Registered date	2013 Year 04 Month 01 Day
Last modified on	2018 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012148