UMIN-CTR Clinical Trial

Basic information
Public title	A phase I trial of weekly Nedaplatin and concurrent thoracic radiotherapy for elderly patients with locally advanced squamous cell lung cancer
Acronym	Nedaplatin and thoracic radiation Phase 1
Scientific Title	A phase I trial of weekly Nedaplatin and concurrent thoracic radiotherapy for elderly patients with locally advanced squamous cell lung cancer
Scientific Title:Acronym	Nedaplatin and thoracic radiation Phase 1
Region	Japan

Condition
Condition	elderly patients with locally advanced squamous cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine the recommended dose and assess the safety of chemoradiotherapy with nedaplatin and thoracic radiation in elderly patients with locally advanced squamous celllung cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	To determine the recommended dose and assess the safety of chemoradiotherapy with nedaplatin and thoracic radiation
Key secondary outcomes	response rate, progression free survival, overall survival, 2 year survival rate, , completion rate of chemoradiotherapy, the rate of occurrence of grade 3 and more radiation pneumonitis

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Combination of Nedaplatin and concurrent thoracic radiotherapy 2Gy/day for 30 times. The dose escalation of Nedaplatin is conducted from 20 to 30 mg/m2 according to standard 3+3 design.
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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1 Cytologically or histologically comfirmed squamous cell carcinoma of the lung 2 Previously untreated and unresectable Stage 3A or 3B 3 patients aged 75 and more years old who are amenable for standard chemo- radiotherapy 4 Eastern Cooperative Oncology Group Performance Status 0 to 1 5 An approval of a radiotherapist by CT simulation based on the restriction of this protcol before registration. 6 Have adequate organ function within two week before study entry a)leukocyte 3000/mm3 or higher b)absolute neutrophil count 1500/mm3 or higher c) hemoglobin consentration 9.0g/dl or higher d) serum AST and ALT 2.5 times of the institutional upper limits of normal or lower e) serum bilirubin 1.5mg/dl or lower f) serum creatinine 1.2mg/dl or lower g) creatinine clearance 60ml/min or higher 7 Have signed an informed consent document
Key exclusion criteria	1) SVC syndrome 2) Pulmonary fibrosis and interstitial pneumonitis 3) With active double cancer 4) With active infection, poorly controlled diabetes, and serious cardiac diseases 5) Patients with steroid treatment 6) Clinically significant drug allergy 7) Uncontrolled psychiatric disease. 8) Positive serum HBs antigen or HCV antibody 9) Others
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuhito Fujisaka
Organization	Osaka medical college hospital
Division name	Cancer research center
Zip code
Address	2-7, Daigakumachi, Takatsuki city, Osaka, Japan
TEL	072-683-1221
Email	fujisaka_y@osaka-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yosuke Tamura
Organization	Osaka medical college hospital
Division name	First Department of Internal Medicine
Zip code
Address	2-7, Daigakumachi, Takatsuki city, Osaka, Japan
TEL	072-683-1221
Homepage URL
Email	in1285@osaka-med.ac.jp

Sponsor
Institute	Osaka medical college hospital
Institute
Department

Funding Source
Organization	Japanese Foundation for Multidisciplinary Treatment of Cancer
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 02 Month 29 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	Terminated
Date of protocol fixation	2016 Year 01 Month 05 Day
Date of IRB	2016 Year 01 Month 06 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date	2018 Year 12 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	2016 Year 02 Month 27 Day
Last modified on	2020 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024462