UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012270 |
|---|---|
| Receipt number | 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 | 2023/05/22 10:58:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Hirohisa |
| Middle name | |
| Last name | Yoshizawa |
Organization
Niigata University Medical and Dental Hospital
Division name
Bioscience Medical Research Center
Zip code
951-8510
Address
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL
025-227-2517
hy0522@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
951-8510
Address
1-754 Asahimachi-Dori,Niigata City, Niigata
TEL
025-368-9325
Homepage URL
satoshi7@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata Lung Cancer Treatment Group
Institute
Department
Personal name
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
Institutional review board of Niigata University
Address
1-754 Asahimachidori, Chuouku, Niigata, 951-8510, Japan
Tel
025-227-2625
ethics@adm.niigata-u.ac.jp
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
| 2023 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014347
