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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039230
Receipt No. 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

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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
Email 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
Email uchino@koto.kpu-m.ac.jp

Sponsor
Institute Clinical Research Support Center Kyushu
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044445

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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