UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039230 |
|---|---|
| Receipt number | R000044445 |
| Scientific Title | Phase II study of 1st-line biweekly Gemcitabine and Carboplatin vs biweekly Gemcitabine and Carboplatin plus maintenance Gemcitabine in elderly patient untreated non-small cell lung cancer |
| Date of disclosure of the study information | 2020/01/23 |
| Last modified on | 2020/01/22 17:12:49 |
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Basic information
Public title
Phase II study of 1st-line biweekly Gemcitabine and Carboplatin vs biweekly Gemcitabine and Carboplatin plus maintenance Gemcitabine in elderly patient untreated non-small cell lung cancer
Acronym
LOGIK0801
Scientific Title
Phase II study of 1st-line biweekly Gemcitabine and Carboplatin vs biweekly Gemcitabine and Carboplatin plus maintenance Gemcitabine in elderly patient untreated non-small cell lung cancer
Scientific Title:Acronym
LOGIK0801
Region
| Japan |
Condition
Condition
advanced/recurrent non-small cell lung cancer (NSCLC)
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess progression-free survival in elderly patients with advanced non-small cell lung cancer (NSCLC) treated with gemcitabine (GEM) maintenance therapy versus best supportive care following first-line GEM plus carboplatin (CBDCA).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PFS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients received biweekly combination therapy with GEM and CBDCA (1000 mg/m2 GEM and CBDCA at an area under the curve of 3 on days 1 and 15, every 4 weeks).
Interventions/Control_2
Patients received biweekly combination therapy with GEM and CBDCA (1000 mg/m2 GEM and CBDCA at an area under the curve of 3 on days 1 and 15, every 4 weeks). Patients with objective response or stable disease following three or four cycles of initial chemotherapy received maintenance GEM .
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
| 70 | 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
90
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
6020841
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
| 2020 | Year | 01 | Month | 23 | 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
83
Results
mPFS(95%CI)
control 4.99mo(3.29-6.28)
maintenance 4.44mo(2.86-6.34)
(p=0.47 log-rank)
Results date posted
| 2020 | Year | 01 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eighty-four patients were enrolled.
Participant flow
The average number of cycles was 2.8, and 28% of patients received maintenance therapy.
Adverse events
Neutropenia was the most common hematologic toxicity in total 37-46%.
Outcome measures
mPFS(95%CI)
control 4.99mo(3.29-6.28)
maintenance 4.44mo(2.86-6.34)
(p=0.47 log-rank)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2008 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | 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
| 2020 | Year | 01 | Month | 22 | Day |
Last modified on
| 2020 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044445
