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
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
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
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
