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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007049
Receipt No. R000008140
Scientific Title Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer
Date of disclosure of the study information 2012/01/18
Last modified on 2019/04/20

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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
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
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

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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