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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012270
Receipt No. R000014347
Scientific Title Phase I / II Study of Alternating Chemotherapy with Cisplatin plus Nogitecan plus Paclitaxel (PlaTT) and Cisplatin plus Amrubicin plus Paclitaxel (PAT) for Advanced Lung Cancer Patients
Date of disclosure of the study information 2013/11/12
Last modified on 2018/06/14

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Basic information
Public title Phase I / II Study of Alternating Chemotherapy with Cisplatin plus Nogitecan plus Paclitaxel (PlaTT) and Cisplatin plus Amrubicin plus Paclitaxel (PAT) for Advanced Lung Cancer Patients
Acronym Phase I / II Study of Alternating Chemotherapy for Advanced Lung Cancer Patients
Scientific Title Phase I / II Study of Alternating Chemotherapy with Cisplatin plus Nogitecan plus Paclitaxel (PlaTT) and Cisplatin plus Amrubicin plus Paclitaxel (PAT) for Advanced Lung Cancer Patients
Scientific Title:Acronym Phase I / II Study of Alternating Chemotherapy for Advanced Lung Cancer Patients
Region
Japan

Condition
Condition Advanced Lung Cancer
Classification by specialty
Medicine in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine MTD and RD in Alternating Chemotherapy with Cisplatin plus Nogitecan plus Paclitaxel (PlaTT) and Cisplatin plus Amrubicin plus Paclitaxel (PAT)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes 1)DLT
2)MTD,RD
Key secondary outcomes 1)toxicity
2)tumor response

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dose of each agent was escalated according to the schedule below.
Combination A
Day 1 2 3 4 5
CDDP x
TPT x x x x
PTX x
Lenograstim x
Combination B
Day 1 2 3 4 5
CDDP x
AMR x x x
PTX x
Lenograstim x
Combination A Combination B
CDDP TPT PTX CDDP AMR PTX
Level 0 40 0.8 100 40 30 100
Level 1 40 1.0 100 40 35 100
Level 2 40 1.2 100 40 40 100
Level 3 40 1.2 120 40 40 120
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
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1) StageIIIB/IV lung cancer proven by histology and/or cytology
2) ineligible for curative RT
3) No prior chemotherapy
4) Age 20<= <70 years PS 0-2
5) At least one or more measurable lesion by RECIST
6) Adequate organ function
7) Life expectancy more than three months.
8) Written Informed Consent
Key exclusion criteria Patients were excluded if they had any active concomitant malignancies,
symptomatic brain metastases, past history of severe allergic reactions to drugs,
interstitial pneumonia identified by chest X-ray, superior vena cava syndrome, or other serious complications, such as uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure,
uncontrolled diabetes mellitus or hypertension, uncontrolled massive pleural
effusion or ascites.
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohisa Yoshizawa
Organization Niigata University Medical and Dental Hospital
Division name Bioscience Medical Research Center
Zip code
Address 1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL 025-227-2517
Email hy0522@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirohisa Yoshizawa
Organization Niigata University Medical and Dental Hospital
Division name Bioscience Medical Research Center
Zip code
Address 1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL 025-227-2517
Homepage URL
Email hy0522@med.niigata-u.ac.jp

Sponsor
Institute Niigata Lung Cancer Treatment Group
Institute
Department

Funding Source
Organization Niigata Lung Cancer Treatment 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
2013 Year 11 Month 12 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 No longer recruiting
Date of protocol fixation
2010 Year 10 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 30 Day
Last follow-up date
2015 Year 10 Month 30 Day
Date of closure to data entry
2015 Year 11 Month 30 Day
Date trial data considered complete
2015 Year 12 Month 30 Day
Date analysis concluded
2016 Year 01 Month 24 Day

Other
Other related information

Management information
Registered date
2013 Year 11 Month 12 Day
Last modified on
2018 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014347

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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