UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

Objective Response Rate (ORR)

Key secondary outcomes

Safety, Progression Free Survival, Overall Survival

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Clinical Research Support Center Kyushu

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

04

Month

25

Day

URL releasing protocol

N/A

Publication of results

Partially published

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

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 related information

Registered date

2019

Year

04

Month

20

Day

Last modified on

2019

Year

04

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041431