UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012989
Receipt number R000015086
Scientific Title Phase II study of Carboplatin plus nab-Paclitaxel for advanced non-small cell lung cancer patients with interstitial lung disease
Date of disclosure of the study information 2014/02/03
Last modified on 2020/07/16 09:33:25

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Basic information

Public title

Phase II study of Carboplatin plus nab-Paclitaxel for advanced non-small cell lung cancer patients with interstitial lung disease

Acronym

Phase II study of CBDCA plus nab-PTX for advanced NSCLC patients with ILD

Scientific Title

Phase II study of Carboplatin plus nab-Paclitaxel for advanced non-small cell lung cancer patients with interstitial lung disease

Scientific Title:Acronym

Phase II study of CBDCA plus nab-PTX for advanced NSCLC patients with ILD

Region

Japan


Condition

Condition

Advanced non-small cell lung cancer with interstitial lung disease

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate safety and efficacy of the combination of nab-Paclitaxel with Carboplatin for advanced non-small cell lung cancer patients with interstitial lung disease

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Exacerbation-free rate of ILD at 28 days after protocol treatment

Key secondary outcomes

Response rate, Progression-free survival, Overall survival, Exacerbation-free rate of ILD, Toxicities


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

4-6 cycles of chemotherapy with nab-Paclitaxl (100 mg/m2/day, day 1, 8, 15) and Carboplatin (AUC=6, day 1) repeated every 3 weeks

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically proven non-small cell lung carcinoma
2) Clinical stage III, IV or recurrent disease after surgery
3) Diagnosed as interstitial lung disease
4) Severity of interstitial lung disease is mild or moderate
5) 20 years of age or older
6) ECOG performance status of 0 or 1
7) No prior chemotherapy for non-small cell lung cancer
8) No prior thoracic radiotherapy
9) With measurable or assessable lesions based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
10) No prior palliative radiotherapy for metastatic lesion within 14 days before registration
11) Adequate organ function
12) Estimated life expectancy of at least 12 weeks
13) Written informed consent

Key exclusion criteria

1) Synchronous or metachronous active double malignancies
2) Other lung disease, including infection, pneumoconiosis, drug-induced pneumonitis, sarcoidosis, and collagen vasucular disease
3) With symptomatic central nervous system metastases
4) Hypersensitvity to platinum or paclitaxel
5) Receiving systemic treatment with steroid or immunosuppressant
6) Positive for hepatitis B surface antigen
7) Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during the treatment period and lactating women.
8) Men who will not be compliant with a contraceptive regimen during and for the treatment period
9) Psychotic disorder which prevent the patient from giving informed consent
10) Other criteria judged by the investigator to make a patient unsuitable for the study

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Terufumi
Middle name
Last name Kato

Organization

Kanagawa Cancer Center

Division name

Department of Thoracic Oncology

Zip code

241-8515

Address

2-3-2 Nakao, Asahi-ku, Yokohama 241-8515, Japan

TEL

045-520-2222

Email

katote@kcch.jp


Public contact

Name of contact person

1st name Hirotsugu
Middle name
Last name Kenmotsu

Organization

Shizuoka Cancer Center

Division name

Division of Thoracic Oncology

Zip code

411-8777

Address

1007 Shimonagakubo Nagaizumi-cho Sunto-gun,Shizuoka, Japan, 411-8777

TEL

055-989-5222

Homepage URL


Email

h.kenmotsu@scchr.jp


Sponsor or person

Institute

Kanagawa Cardiovascular and Respiratory Center

Institute

Department

Personal name



Funding Source

Organization

The study group on diffuse pulmonary disorders

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shizuoka Cancer Center IRB

Address

1007 Shimonagakubo, Nagaizumi-cho

Tel

0559895222

Email

h.kenmotsu@scchr.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

国立がん研究センター中央病院(東京都)、横浜市立市民病院(神奈川県)、国立がん研究センター東病院(千葉県)、岡山大学(岡山県)、和歌山県立医科大学(和歌山県)、順天堂大学医学部附属順天堂医院(東京)、埼玉医科大学国際医療センター(埼玉県)、神奈川県立循環器呼吸器病センター(神奈川県)、静岡県立静岡がんセンター(静岡県)


Other administrative information

Date of disclosure of the study information

2014 Year 02 Month 03 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

Main results already published

Date of protocol fixation

2013 Year 12 Month 16 Day

Date of IRB

2014 Year 04 Month 22 Day

Anticipated trial start date

2014 Year 06 Month 10 Day

Last follow-up date

2018 Year 01 Month 09 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 28 Day

Last modified on

2020 Year 07 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015086


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name