UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012901
Receipt number R000015075
Scientific Title Carboplatin and nab-Paclitaxel as first-line treatment in patients with advanced non-small cell lung cancer with interstitial lung disease (HOT1302)
Date of disclosure of the study information 2014/01/20
Last modified on 2020/02/22 10:13:22

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Basic information

Public title

Carboplatin and nab-Paclitaxel as first-line treatment in patients with advanced non-small cell lung cancer with interstitial lung disease (HOT1302)

Acronym

Carboplatin and nab-Paclitaxel as first-line treatment in patients with advanced non-small cell lung cancer with interstitial lung disease (HOT1302)

Scientific Title

Carboplatin and nab-Paclitaxel as first-line treatment in patients with advanced non-small cell lung cancer with interstitial lung disease (HOT1302)

Scientific Title:Acronym

Carboplatin and nab-Paclitaxel as first-line treatment in patients with advanced non-small cell lung cancer with interstitial lung disease (HOT1302)

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of carboplatin and nab-paclitaxel as first-line therapy in patients with advanced non-small cell lung cancer with interstitial lung disease

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Objective response rate

Key secondary outcomes

Safety, progression-free survival, overall survival


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

Nab-paclitaxel 100mg/m2 is administered by an infusion lasting 30 minutes on days 1, 8, 15 every 3weeks.
Carboplatin AUC 6 is administered by an infusion lasting 60 minutes on day 1 following to nab-paclitaxel 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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) Age of 20 years or older and younger than 75 years
2) Histologically or cytologically confirmed non-small cell lung cancer
3) Clinical Stage IIIB which curative radiotherapy is not indicated, IV or postoperative recurrence
4) No prior chemotherapy
5) Patients with interstitial lung disease diagnosed by chest X-ray or Chest CT scan
6) Measurable lesion(s)
7) ECOG Performance status of 0-1
8) Sufficient major organ function
9) Life expectancy of at least 3 months
10) Written informed consent

Key exclusion criteria

1) History of Severe drug allergies
2) CVD-IP or other ILD (e.g. pneumoconiosis) with clear cause
3) Active infection
4) Oral steroid or immunosuppressant drug
5) Severe concurrent disease
6) Postive HBs antigen or positive HBs antibody with detectable HBV-DNA
7) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion
8) Symptomatic brain metastasis
9) Active double cancer
10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy
11) Previous treatment with nab-paclitaxel
12) Physician concludes that the patient's participation in this trial is inappropriate

Target sample size

35


Research contact person

Name of lead principal investigator

1st name Satoshi
Middle name
Last name Oizumi

Organization

Hokkaido University Schoole of Medicine

Division name

First Department of Medicine

Zip code

060-8638

Address

North 15, West 7, Kita-ku, Sapporo

TEL

011-706-5911

Email

soizumi@med.hokudai.ac.jp


Public contact

Name of contact person

1st name Hajime
Middle name
Last name Asahina

Organization

Hokkaido University Schoole of Medicine

Division name

First Department of Medicine

Zip code

060-8638

Address

North 15, West 7, Kita-ku, Sapporo

TEL

011-706-5911

Homepage URL


Email

asahinah@pop.med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido Lung Cancer Clinical Study Group

Institute

Department

Personal name



Funding Source

Organization

Hokkaido Lung Cancer Clinical Study 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

Hokkaido University IRB

Address

Kita 14, Nishi 5, Kita-ku, Sapporo, Japan

Tel

011-706-7636

Email

crjimu@huhp.hokudai.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

2014 Year 01 Month 20 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/31654836

Number of participants that the trial has enrolled

36

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

2014 Year 01 Month 16 Day

Date of IRB

2014 Year 01 Month 20 Day

Anticipated trial start date

2014 Year 01 Month 20 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 20 Day

Last modified on

2020 Year 02 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015075


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name