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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019458
Receipt No. R000021929
Scientific Title Phase 2 study of Carboplatin plus nab-Paclitaxel for patients with PS 2 advanced NSCLC(TORG1426)
Date of disclosure of the study information 2015/10/22
Last modified on 2019/04/24

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Basic information
Public title Phase 2 study of Carboplatin plus nab-Paclitaxel for patients with PS 2 advanced NSCLC(TORG1426)
Acronym Phase 2 study of Carboplatin plus nab-Paclitaxel for PS 2 advanced NSCLC (TORG1426)
Scientific Title Phase 2 study of Carboplatin plus nab-Paclitaxel for patients with PS 2 advanced NSCLC(TORG1426)
Scientific Title:Acronym Phase 2 study of Carboplatin plus nab-Paclitaxel for PS 2 advanced NSCLC (TORG1426)
Region
Japan

Condition
Condition Non small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy and safety With combination of Carboplatin and nab-Paclitaxel
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 6-month PFS rate
Key secondary outcomes PFS, overall survival, response rate, desease control rate, toxicities, 1-year survival rate, QOL

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 Carboplatin (day 1, AUC=5) and nab-Paclitaxel(day 1, 8, 15, 70mg/m2) Q4weeks, maximum 6 courses.
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
74 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically confirmed advanced non-squamous non-small-cell lung cancer
2) Clinical stage III (not amenable to curative radiation), IV or recurrent disease
3) patients without prior chemotherapy or curative radiotherapy for lung cancer
4) aged 20 - 74 years old
5) No matter EGFR or EML4-ALK mutation
6) patients who have at least one or more measurable lesion by RECIST v.1.1
7) ECOG (Eastern Cooperative Oncology Group) PS
8) Adequate organ function and laboratory findings as below(within 14 days prior registration);
- WBC > 3,000/mm3
- neutrophil > 1,500/mm3
- platelet > 100,000/mm3
- hemoglobin > 9.0g/dl
- AST, ALT < 100IU/L
- total bilirubin < 1.5mg/dl
- Ccr >45mL/min(Cockcloft-Gault mothod)
- SpO2 > 90%(room air)
9) Life expectancy more than 2months
10) Symptomatic brain metastasis is allowed,if symptoms are comtrolled (14 days after surgery and/or radiotherapy)
11) Written informed consent
Key exclusion criteria 1) Patients with serious infection and/or serious complications(gastrointestinal bleeding, or cardiac disorder, etc)
2) Patients with interstitial pneumonia (by Chest X-P)
3) Patients with prior radiotherapy to primary and /or target region.
4) Patient who is with contraindications to paclitaxel or carboplatin.
5) History of hypersensitivity for albumin products
6) History of poorly controlled pleural effusion,pericardial effusion and ascites
7) Patients with severe renal dysfunction
8) Patients with symptomatic brain metastases
9) Patients with active double cancer less than 5 years disease free period
10) History of Bone-marrow transplantation
11) History of Peripheral blood stem cell transplantation(PBSCT)
12) Patients who declined contraception.
13) Patients with uncontrollable diabetes or hypertension
14) Patients with hepatic cirrhosis
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiko Seki
Organization Teikyo University, School of Medicine
Division name Department of Medical Oncology
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo
TEL 03-3964-1211
Email nseki@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuko Ichikawa
Organization Teikyo University, School of Medicine
Division name Department of Medical Oncology
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo
TEL 03-3964-1211
Homepage URL
Email icchi@med.teikyo-u.ac.jp

Sponsor
Institute NPO Thoracic Oncology Research Group
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2015 Year 10 Month 22 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 Completed
Date of protocol fixation
2015 Year 03 Month 17 Day
Date of IRB
2015 Year 09 Month 01 Day
Anticipated trial start date
2015 Year 11 Month 24 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 22 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021929

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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