UMIN-CTR Clinical Trial

Public title

A randomized phase 2 study of TS-1 versus CDDP+VNR for adjuvant therapy in patients with non-small cell lung cancer

Acronym

LOGIK1702

Scientific Title

A randomized phase 2 study of TS-1 versus CDDP+VNR for adjuvant therapy in patients with non-small cell lung cancer

Scientific Title:Acronym

LOGIK1702

Region

Japan

Condition

Non-small-cell lung cancer

Classification by specialty

Medicine in general	Pneumology	Hematology and clinical oncology
Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We evaluate effectiveness and safety of TS-1 monotherapy and CDDP+VNR combination therapy in patients with II/IIIA stage non-small-cell lung cancer which underwent a total resection. In addition, we also carry out the search of QOL and a productivity of the work and an activity disorder. At the same time, we intend to obtain information required to perform phase 3 randomized controlled trials planned in future precisely.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Two year relapse free survival

Key secondary outcomes

Treatment completion rate, incidence of adverse event, relative dose density, 2 year overall survival, 5 year overall survival, 2 year relapse free survival, 5 year relapse free survival, productivity of the work and activity disorder, quality of adjusted life year (QALY) converted from EQ-5D-5L.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Arm A (TS-1 monotherapy): adjuvant therapy of TS-1 for 16 courses (1 year)
TS-1 80mg/m2 is orally administered twice dairy (after breakfast and dinner) from after breakfast at day 1 to after dinner at day 14 (or from after dinner at day1 to after breakfast at day 15) as 21 days of 1 course.

Interventions/Control_2

Arm B (CDDP + VNR combination therapy):TS-1 monotherapy): adjuvant therapy of CDDP+VNR for 4 courses
CDDP 80mg/m2 at day1 and VNR 25mg/m2 at day 1, 8 are administered as 21 days of 1 course for 4 courses.

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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)Patients providing the written informed consent.
2)Patients with non-small-cell lung cancer histopathologically confirmed (except neuroendocrine carcinoma, mucoepidermoid carcinoma, adenoid cystic carcinoma).
3)Patients with total resection in pathological clinical stage II - IIIA which more than one lobe excision was carried out.
4)Patients with lymphadenectomy more than ND2a-1 or selective lymphadenectomy.
The selection method of the mediastinal lymph node should be dissected obeys the following criteria.
Right upper lobe lung cancer LC No.2R,4R
Left upper lobe segmentum superius LC No. 4L-6
Right middle lobe LC No.2R,4R,7
Left upper lobe lingual LC No.4L-7
Right lower lobe LC No.7-9
Left lower lobe LC No.7-9
5)Patients without pre-treatment(radiation,chemotherapy)other than surgical treatment.
6)Patients who passed more than 28 days and less than 56days after the operation at the enrollment (it is eligible on the same day 4 weeks and 8 weeks before the enrolment day).
7)Patient is at least 20 years and less than 75 years of age (at enrollment date).
8)Patients capable of treatment with oral medicine.
9)Performance status(ECOG):0-1
10)Patients having sufficient bone marrow,liver and renal function tolerable to chemotherapy(however,the following clinical laboratory test should be confirmed by the data within 14 days prior to enrollment).
White blood cell count 3,000-12,000/mm3
Platelet count >= 100,000/mm3
Haemoglobin >= 9.0g/dL
Total bilirubin <= 1.5mg/dL
AST, ALT <=100 IU/ml
BUN <= 25mg/dL
SpO2 >=90% or PaO2 >= 70 mmHg
Creatinine <= 1.5mg/dL
Creatinine clearance >= 60 ml/min
(actual value or converted value from serum creatinine level by Cockcroft-Gault formula)

Key exclusion criteria

1)Patients with active double cancer (synchronous double cancer and asynchronous double cancer within 5 years of progression-free period. However, the lesions correspondent to carcinoma in situ of uterine cervix curable by topical treatment, resectable gastric cancer/colorectal cancer by endoscope and topically resectable skin cancer other than malignant melanoma are excluded from active double cancer).
2)Patients with anamnesis of drug-induced hypersensitivity.
3)Patients with severe postoperative complications (such as postoperative infection, rapture suture).
4)Patients with severe complications (such as diarrhoea, intestinal paralysis, ileus, uncontrollable diabetes mellitus, heart failure, kidney failure, liver failure).
5)Patients with interstitial pattern recognized as apparent interstitial pneumonia in chest CT.
6)Patients with active infection.
7)Female patients with pregnant or possibly pregnant (will), or nursing.
8)Patients under treatment of type of fluorinated pyrimidine antineoplastic.
9)Patients under treatment of flucytosine.
10)Any other patients who are regarded as unsuitable for this study by the investigators.

Target sample size

190

Name of lead principal investigator

1st name	Takeshi
Middle name
Last name	Nagayasu

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Division of Surgical Oncology,

Zip code

852-8501

Address

1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan

TEL

095-819-7304

Email

nagayasu@nagasaki-u.ac.jp

Name of contact person

1st name	Tomoshi
Middle name
Last name	Tsuchiya

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Division of Surgical Oncology,

Zip code

852-8501

Address

1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan

TEL

095-819-7304

Homepage URL

Email

tomoshi@nagasaki-u.ac.jp

Institute

Clinical Research Support Center Kyushu

Institute

Department

Personal name

Organization

Taiho Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

1)Lung Oncology Group in Kyushu(LOGIK)

Name of secondary funder(s)

Organization

Nagasaki University Hospital Clinical Research Ethics Committee

Address

1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan

Tel

095-819-7905

Email

gaibushikin@ml.nagasaki-u.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

長崎大学病院（長崎県）

Date of disclosure of the study information

2017

Year

05

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

2

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2017

Year

05

Month

02

Day

Date of IRB

2017

Year

05

Month

16

Day

Anticipated trial start date

2017

Year

06

Month

01

Day

Last follow-up date

2020

Year

11

Month

07

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

05

Month

22

Day

Last modified on

2020

Year

11

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031434