UMIN-CTR Clinical Trial

Basic information
Public title	Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer
Acronym	Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer(TCOG1101)
Scientific Title	Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer
Scientific Title:Acronym	Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer(TCOG1101)
Region	Japan

Condition
Condition	Advanced non-small-cell lung cancer in elderly patients
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine the recommend dose of TS-1 plus CBDCA chemotherapy, and to investigate the efficacy and safety of the recommend dose in elderly patients with advanced non-small-cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I study: MTD, RD Phase II study : Response rate in RD
Key secondary outcomes	Phase I study: Safety Phase II study : OS, PFS and Safety

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	Level0 CBDCA :AUC4(day1)+ S-1:65mg/m2(day1-14) q3weeks Level1 CBDCA :AUC4(day1)+ S-1:80mg/m2(day1-14) q3weeks Level2 CBDCA :AUC5(day1)+ S-1:80mg/m2(day1-14) q3weeks
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)Patients with histlogically or cytologically confirmed non-small cell lung cancer 2)Patients with clinical stage of IIIB-IV or recurrence after operation 3)Elderly patients over 75 years old 4)ECOG Performance status 0-1 5) Expected survival more than 3 months 6)A measurable lesion according to the Response Evaluation Criteria in Solid Tumors 7) With ability of oral intake 8)No prior chemotherapy nor radiation therapy 9)Adequate bone marrow reserve and organ function 10)Written IC
Key exclusion criteria	1)Patients with interstitial pneumonia or pulmonary fibrosis on Chest X-ray 2)Patients with pleural or pericardial effusion ,or ascites 3) Patients with active double cancer 4)Patients with significant complications a) Uncontrolled angina pectoris, myocardial infarction, heart failure within 3 months b)Uncontrolled diabetes or hypertension c)Current severe infection, or suspicious of severe infection d) Patients whose participation in the trial is judged to be inappropriate by the attending doctor. (e.g., ileus, bleeding tendency, diarrhea and varicella) 5)Patients with symptomatic brain metastasis 6)Patients with pregnancy or lactation 7) History of serious drug allergy 8) History of serious allergic reaction with CBDCA or other platinum-containing drug 9) History of serious allergic reaction with S-1 10) Being treated with other pyrimidine fluoride antineoplastic agents. 11) Being treated with flucytosine. 12) Any patients judged by the investigator to be unfit to participate in the study
Target sample size	35

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Takashi KASAI
Organization	Tochigi Cancer Center
Division name	Division of Thoracic Oncology
Zip code
Address	4-9-13 Yonan Utsunomiya City Tochigi
TEL	028-658-5151
Email	tcog1101@tcog.jp

Public contact
1st name of contact person	1st name Middle name Last name TCOG1101study affairs office
Organization	The Tokyo Cooperative Oncology Group
Division name	Clinical Study Promotion Agency
Zip code
Address	Toa-Bldg 4F 2-1-18 Hamamatsu-cho Minato-ku Toky
TEL	03-5401-5020
Homepage URL
Email	tcog1101@tcog.jp

Sponsor
Institute	The Tokyo Cooperative Oncology Group
Institute
Department

Funding Source
Organization	The Tokyo Cooperative Oncology Group
Organization
Division
Category of Funding Organization	Self funding
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	2012 Year 01 Month 18 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	Completed
Date of protocol fixation	2011 Year 11 Month 29 Day
Date of IRB	2011 Year 07 Month 27 Day
Anticipated trial start date	2012 Year 02 Month 01 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2012 Year 01 Month 11 Day
Last modified on	2019 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008140