UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011216 |
|---|---|
| Receipt number | 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 | 2020/11/26 10:10:55 |
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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 | Yuichiro |
| Middle name | |
| Last name | Ohe |
Organization
National Cancer Center Hospita
Division name
Department of Thoracic Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
yohe@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Zenke |
Organization
National Cancer Center Hospital East
Division name
Department of Thoracic Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
Homepage URL
siniho@east.ncc.go.jp
Sponsor or person
Institute
Thoracic Oncology Research Group
Institute
Department
Personal name
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
National Cancer Center East Hospital ethics committee
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
Tel
04-7133-1111
-
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 | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012975
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