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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036556
Receipt No. R000041431
Scientific Title Randomized, phase II study of weekly paclitaxel plus carboplatin versus biweekly paclitaxel plus carboplatin for patients with previously untreated advanced non-small-cell lung cancer
Date of disclosure of the study information 2019/04/25
Last modified on 2019/04/20

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Basic information
Public title Randomized, phase II study of weekly paclitaxel plus carboplatin versus biweekly paclitaxel plus carboplatin for patients with previously untreated advanced non-small-cell lung cancer
Acronym LOGIK-0403
Scientific Title Randomized, phase II study of weekly paclitaxel plus carboplatin versus biweekly paclitaxel plus carboplatin for patients with previously untreated advanced non-small-cell lung cancer
Scientific Title:Acronym LOGIK-0403
Region
Japan Asia(except Japan)

Condition
Condition advanced non-small cell lung cancer (NSCLC)
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety of the weekly and biweekly CP regimen for patients with advanced NSCLC.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Objective Response Rate (ORR)
Key secondary outcomes Safety, Progression Free Survival, Overall Survival

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 A group: Biweekly treatment
TXL 135mg/m2 day1, 15+CBDCA(AUC=3)day1, 15
every 28 days for 4 cycles
Interventions/Control_2 B group: Weekly treatment
TXL 90mg/m2 day1, 8, 15 + CBDCA(AUC=6) day1
every 28 days for 4 cycles
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Cases of non-small cell lung cancer confirmed by cytology or histology
Stage IIIB (radiotherapy-naive cases) and Stage IV (postoperative distant metastases are treated as Stage IV)
Cases without prior chemotherapy for this disease
Age 20 to 80 years
PS(ECOG) 0-1
Cases with measurable lesions according to RECIST criteria
Cases with adequate major organ function
1) WBC count > 4,000 per mm3 Or more than 2000 neutrophils per mm3
2) Platelets count > 10000 per mm3
3) Hemoglobin > 9.0/dL
4) GOTs, not more than 2 times the upper limit of normal at GPT institution
(However, abnormal values due to liver metastasis are not more than 3 times the upper limit of normal.)
5) Serum total bilirubin < 1.5 mg/dL
6) Upper limit of normal for serum creatinine 1.5-fold or less
7) Electrocardiogram normal (patients without serious heart disease or arrhythmia)
8) PaO2 60 torr or higher (or SpO2 90% or higher)
Patients with an expected survival of at least 3 months
Written informed consent has been obtained from the patient regarding participation in the study
Key exclusion criteria Cases with serious complications
(e.g., severe heart disease or cerebrovascular disorders, difficult-to-control diabetes or hypertension, Severe infection, pulmonary fibrosis, interstitial pneumonia, respiratory failure, hemorrhage, massive pleural effusion, or ascites, Retention, active peptic ulcers, and serious neurologic disease)
Cases with symptomatic brain metastases
Cases with active double cancers
Patients with a history of serious drug hypersensitivity
Polyoxyethylene castor oil-containing preparation (cyclosporine preparation)
Patients who have experienced hypersensitivity related to a history of administration of a sclerosed castor oil-containing preparation (e.g., an injectable vitamin preparation)
Cases with a history of alcohol hypersensitivity
Pregnant, lactating and possibly pregnant women
Patients with psychosis or psychiatric symptoms who are considered difficult to participate in the study
Patients receiving continuous systemic (oral or intravenous) corticosteroids
Other cases considered inappropriate by the attending physician
Target sample size 140

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 602-8566
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
TEL 075-251-5513
Email takayama@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 602-8566
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, 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, Kawaramachi-Hirokoji, 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
2019 Year 04 Month 25 Day

Related information
URL releasing protocol N/A
Publication of results Partially published

Result
URL related to results and publications N/A
Number of participants that the trial has enrolled 140
Results
Objective response rates (ORRs) were 29.6% (B) and 37.6% (W). The most common toxicity was neutropenia, 49.0% (W) and 52.3% (W). Progression free survivals were 4.3m (B) and 5.1 m (W) in Japanese, and 3.1m (B) and 6.7m (W) in Korean, respectively. Overall survivals were 14.2m (B) and 13.3m (W) in Japanese, and 12.7m (B) and 22.1m (W) in Korean, respectively.
Results date posted
2019 Year 04 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
140 patients in Japan and 72 patients in Korea were enrolled onto the study at 13 sites in Japan and 4 sites in Korea. After excluding 5 ineligible cases, 135 patients in Japan and 72 patients in Korea were assessed.
Participant flow
In the biweekly arm, the average number of cycles was 2.8, and 45% of patients received 4 cycles. In the weekly arm, the average number of cycles was 3.0, and 53% of patients received 4 cycles. The median number of cycles in both arms was 3 and 3 for the biweekly and weekly arm, respectively. 
Adverse events
Neutropenia was the most common hematologic toxicity in total and each country with no statistical difference between weekly arm and biweekly arm, 52.3% vs. 49.0%, respectively. Anemia, leucopenia and thrombocytepenia were significantly higher in the weekly arm compared with those in biweekly arm, 21.2% vs. 2.0% (p<0.01), 30.3% vs. 15.3% (p<0.05) and 6.4% vs. 0% (p<0.05), respectively. Although the similar trend was noted in both countries, hematologic toxicities were more frequent in Japan than Korea. Non-hematological toxicities were generally mild and manageable in both countries. However, it is important to note that the frequency of infection was significantly higher in biweekly arm, 1.8% vs. 11.2%, respectively (p<0.01). Moreover, two patients died as a result of pneumonia in the biweekly arm in Korea. Since the grade of hematologic toxicities were generally low intensity in biweekly arm as described above, other factors except myelosupprssion may be associated with the infectious disease.
Outcome measures
ORRs in the biweekly and weekly arm were 29.6% and 37.6%, respectively. Although weekly arm showed the higher response rate, there was no significant difference between two arms (p=0.24). The ORR was 28.1% in the biweekly arm and 38.0% in the weekly arm in Japanese population (p=0.27), and 32.4% in the biweekly arm and 36.8% in the weekly arm in Korean population (p=0.81). No statistical difference in the response rate in the biweekly and weekly regimens was noted in each country. In Japan, however, the response rate of 38.0% in the weekly arm was significantly higher than the threshold response rate (p=0.01). On the other hand, the ORR of the biweekly regimen was not significant (p=0.33). In Korea, the ORR in the weekly arm also tended to be higher than the threshold (p=0.07). 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2004 Year 11 Month 08 Day
Date of IRB
2005 Year 04 Month 18 Day
Anticipated trial start date
2005 Year 12 Month 01 Day
Last follow-up date
2010 Year 09 Month 30 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 04 Month 20 Day
Last modified on
2019 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041431

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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