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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011216
Receipt No. R000012975
Scientific Title Combination chemotheraoy of abraxane and carboplatin in elderly patients with advanced squamous cell lung cancer, phase 1/2 study (TORG1322)
Date of disclosure of the study information 2013/07/18
Last modified on 2020/07/13

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Basic information
Public title Combination chemotheraoy of abraxane and carboplatin in elderly patients with advanced squamous cell lung cancer, phase 1/2 study (TORG1322)
Acronym Abraxane + CBDCA in elderly patients with advanced squamous cell lung cancer, phase 1/2 study (TORG1322)
Scientific Title Combination chemotheraoy of abraxane and carboplatin in elderly patients with advanced squamous cell lung cancer, phase 1/2 study (TORG1322)
Scientific Title:Acronym Abraxane + CBDCA in elderly patients with advanced squamous cell lung cancer, phase 1/2 study (TORG1322)
Region
Japan

Condition
Condition Advanced squamous cell lung cancer in elderly patients
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the recommended dose of abraxane and carboplatin combination chemotherapy in elderly patients with advanced squamous cell lung cancer and
to assess the efficacy and safety with recommended dose
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes <Phase I portion>
To determine the recommended dose
<Phase II portion>
Progression-free survival rate at 6 months
Key secondary outcomes Overall survival (OS)
Progression-free survival (PFS)
Response rate(RR)
Rate of adverse events

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 and abraxane
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically proven squamous cell lung cancer
2) Stage IV or stage III without any indications for radiotherapy
3) No prior chemotherapy
4) ECOG performance status 0-1
5) Measurable disease (RECIST ver.1.1)
6) Aged >=75
7) Adequate organ function
8) Estimated life expectancy at least 3 months
9) Written informed consent by patient
Key exclusion criteria 1) Active multiple malignancy
2) History of hypersensitivity for albumin products
3) Severe drug allergy
4) Within 2 weeks after palliative radiotherapy
5) Uncontrolled symptomatic brain metastasis
6) Uncontrolled pleural effusion, ascites, and pericardial effusion which needs drainage
7) Uncontrollable ulcer of digestive tract or diabetes
8) Interstitial pneumonia
9) Psychiatric disease or symptoms, who seem to have difficulty in participating in the study
10) Other severe complications
11) Judged to be not suitable by the attending physician
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichiro Ohe
Organization National Cancer Center Hospital East
Division name Department of Thoracic Oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577
TEL 04-7133-1111
Email yohe@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Zenke, Shigeki Umemura, Seiji Niho
Organization National Cancer Center Hospital East
Division name Department of Thoracic Oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577
TEL 04-7133-1111
Homepage URL
Email siniho@east.ncc.go.jp

Sponsor
Institute Thoracic Oncology Research Group
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 国立がん研究センター東病院(千葉県)

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 18 Day

Related information
URL releasing protocol https://www.lungcancerjournal.info/article/S0169-5002(20)30425-6/fulltext#secsect0005
Publication of results Published

Result
URL related to results and publications https://www.lungcancerjournal.info/article/S0169-5002(20)30425-6/fulltext#secsect0005
Number of participants that the trial has enrolled 46
Results
The 6 m PFS rate was 59.4% (90% confidence interval [CI], 44.8% - 71.4%), and the primary endpoint was met.
Results date posted
2020 Year 07 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 05 Month 20 Day
Baseline Characteristics
In this phase I study, the doses of carboplatin at an area under the curve (AUC) of 5 or 6 mg/mL/min on day 1 (levels 1 and 2, respectively) were administered along with weekly nab-PTX (100 mg/m 2) on days 1, 8, and 15 every 4 weeks for up to 6 cycles using a modified 3 + 3 design. The primary endpoint for the phase II study was the 6-month progression-free survival (6 m PFS) rate.
Participant flow
A total of 46 patients were enrolled in this study. Ten patients were enrolled in the phase I part. The recommended dose was determined to be level 2. Efficacy was then evaluated in 39 patients enrolled in a phase II study. 
Adverse events
Phase 1: At dose level 1, 2/7 patients showed dose-limiting toxicities (DLTs) of grade 3 diarrhea and febrile neutropenia; at dose level 2, 1/3 patient exhibited grade 3 anorexia as a DLT.
Phase 2: Common grade 3 or 4 toxicities were neutropenia (61.5%), anemia (46.2%), thrombocytopenia (17.9%), and febrile neutropenia (15.4%).
Outcome measures
 Efficacy was then evaluated in 39 patients enrolled in a phase II study. The median number of cycles was 4 (range, 1-6), and the median follow-up time was 17.5 months (range, 5.6-28.9 months). The 6 m PFS rate was 59.4% (90% confidence interval [CI], 44.8%-71.4%), and the primary endpoint was met. The median overall survival time was 23.5 months (95% CI, 11.6-35.4), and the median PFS was 6.8 months (95% CI, 5.4-9.1). The response rate was 54%, and the disease control rate was 92%. Sixteen patients (41%) received immune checkpoint inhibitors post-study.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 06 Month 17 Day
Date of IRB
2013 Year 10 Month 08 Day
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2019 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 18 Day
Last modified on
2020 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012975

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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