UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037280 |
|---|---|
| Receipt number | R000041395 |
| Scientific Title | Phase II study on biweekly combination therapy of gemcitabine plus carboplatin for the treatment of elderly patient with advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2019/07/10 |
| Last modified on | 2019/07/05 13:34:58 |
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Basic information
Public title
Phase II study on biweekly combination therapy of gemcitabine plus carboplatin for the treatment of elderly patient with advanced non-small cell lung cancer
Acronym
LOGIK0406
Scientific Title
Phase II study on biweekly combination therapy of gemcitabine plus carboplatin for the treatment of elderly patient with advanced non-small cell lung cancer
Scientific Title:Acronym
LOGIK0406
Region
| Japan |
Condition
Condition
advanced/recurrent non-small cell lung cancer (NSCLC)
Classification by specialty
| Medicine in general | Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and tolerability of gemcitabine plus carboplatin for elderly patients with chemotherapy-naive non-small-cell lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Rresponse rate (RR)
Key secondary outcomes
Progression free survival (PFS)
Overall survival (OS)
Safety
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
1000mg/m2 of Gemcitabine plus AUC 3 of carboplatin were administered every two weeks and was continued until disease progression
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) Patients with histologically proven non-small cell lung cancer
(2) Patients with measurable disease
(3) Chemotherapy in patients with unreliable Stage IIIb and Stage IV or in patients with postoperative relapse
Untreated patients
(4) Patients with a clinical signs Performance Status of 0 to 1
(5) Patients aged 70 years or older at enrollment
(6) Patients who have not received prior chemotherapy, radiation therapy, or immunotherapy (BRM)
(7) Major organ functions (bone marrow, liver, kidney, etc.) are well preserved, and the following criteria are used
Patients who meet
WBC count: 4,000 per mm3 and 12,000 per mm3
Neutrophils: 2,000 per mm3 or more
Platelets count: 100,000 per mm3 or more
Haemoglobin: 9.0 g/dl or more
GOT and GPTs: less than 2.5 times the normal values of the institution
Total bilirubin: not more than 2.0 mg/dl
Serum creatinine: not more than 1.2 mg/dl
PaO2 :>= 60 Torr
(8) Patients who are expected to survive for more than 3 months
(9) Patients with written informed consent to participate in the study
Key exclusion criteria
(1) Patients with obvious infections
(2) Patients with fever (38C or higher)
(3) Serious complications (heart disease, pulmonary fibrosis/interstitial pneumonia, bleeding tendency, uncontrolled)
Patients with hypertension, diabetes mellitus, etc.
(4) Patients with active double cancer (disease-free interval <5 years)
(5) Symptomatic patients with brain metastases
(6) Patients with pleural effusions and ascites requiring treatment
(7) Patients with pericardial effusion
(8) Patients with varicella
(9) Patients with motor paralysis or peripheral nerve symptoms (excluding those originating from the primary disease)
(10) Patients with a history of drug hypersensitivity
(11) Pregnant, breastfeeding, and women of childbearing potential (willingness)
(12) Other patients judged inappropriate by the investigator
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Takayama |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Pulmonary Medicine
Zip code
6020841
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5513
uchino@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Uchino |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Pulmonary Medicine
Zip code
602-0841
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5513
Homepage URL
uchino@koto.kpu-m.ac.jp
Sponsor or person
Institute
Clinical Research Support Center Kyushu
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Kyoto prefectural University of Medicine
Address
465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto 602-8566, Japan
Tel
075-251-5513
uchino@koto.kpu-m.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
| 2019 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
48
Results
ORR: 29.2%(95%CI: 17.0-44.1)
PFS: 178days(95%CI 122-198)
OS: 398days
Results date posted
| 2019 | Year | 07 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
48 patients were enrolled onto the study at 18 sites
Participant flow
The average number of cycles was 7, and 42% of patients received 8 cycles.
Adverse events
Neutropenia was the most common hematologic toxicity in total 68.8%.
Outcome measures
ORR: 29.2%(95%CI: 17.0-44.1)
PFS: 178days(95%CI 122-198)
OS: 398days
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2004 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2005 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2005 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 05 | Day |
Last modified on
| 2019 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041395
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
