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

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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 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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name