UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009872
Receipt number R000011568
Scientific Title Phase II study of continuation maintenance by use of TS1 after induction chemotherapy of cisplatin and TS1 in patients with Stage IIIB / IV non-small cell lung cancer-Research of efficacy predictive biomarker
Date of disclosure of the study information 2013/01/31
Last modified on 2019/03/30 15:23:49

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Basic information

Public title

Phase II study of continuation maintenance by use of TS1 after induction chemotherapy of cisplatin and TS1 in patients with Stage IIIB / IV non-small cell lung cancer-Research of efficacy predictive biomarker

Acronym

Phase II of cisplatin and TS1 followed by TS1

Scientific Title

Phase II study of continuation maintenance by use of TS1 after induction chemotherapy of cisplatin and TS1 in patients with Stage IIIB / IV non-small cell lung cancer-Research of efficacy predictive biomarker

Scientific Title:Acronym

Phase II of cisplatin and TS1 followed by TS1

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of cisplatin and TS1 followed by TS1 in patients with Stage IIIB / IV non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Progression free survival from the beginning of maintenance therapy

Key secondary outcomes

Response rate by RECIST, Overall survival, Time to treatment failure,
Adverse events, Quality of life, Efficacy predictive factors (Thymidylate synthase, Dihydoropyrimidine dehydrogenase, others)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Cisplatin and TS1 followed by TS1


the other trial of same chemotherapy with bevacizumab at same time

Interventions/Control_2


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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

Eligibility criteria for Pre-registration
1) Histologically or cytologically proven non-small cell lung cancer
2) Stage IIIB/IV without indication for radical thoracic irradiation or recurrence after surgical treatment
3) Naive treatment of cytotoxic chemotherapy.
Treatments below are acceptable for pre-registaration
a) Palliative Irradiation except primary tumor of lung more than 2 weeks ago
b)First line treatment by epidermal growth factor receptor-tyrosine kinase inhibitors more than 2 weeks ago
c)post-operation adjuvant therapy more than 6 months.
4)Eastern Cooperative Oncology Group performance status of 0-1
5)Age; > or = 20 years and < 75 years
6) Tumor has the evaluable lesion.
7) capable of oral intake
8) Adequate organ function, Adequate organ function within 2 weeks
a) Leukocyte count; > or = 3,000/mm3
b) Neutrophil count; > or = 1,500/mm3
c) Platelet count; > or = 100,000/mm3
d) Hemoglobin concentration; > or = 10.0g/dl
e) Total bilirubin level; < or = 2.0 mg/dl
f) Aspartate aminotransferse and alanine aminotransferase levels; < or = 100 IU/L
g) PaO2; > or = 60 Torr or SpO2; > or = 90% at room air
h) Creatinine clearance; > or = 60mL/min
9) Estimating Survival more than 12 weeks
10)Written informed consent

II)Eligibility criteria for registration
1) More than 2 cycles of induction chemotherapy
2) Response criteria of induction chemotherapy achieved more than and equal to SD.
3) Maintenance start within 6 weeks after start of TS1 of last cycle.

Key exclusion criteria

1) History of allergic reaction for agents of present treatment
2) Severe myelosupperssion, renal dysfunction or hepatic dysfunction
3) Patients received post-operation adjuvant therapy within 6 months.
4) Active concomitant malignancy except carcinoma in situ, intramucosal carcinoma or cancer with more than 5 year disease free
5) Significant comorbid disease such as paresis of intestine, ileus, interstitial pneumonia, lung fibrosis, uncontrolled diabetes mellitus, cardiac failure, renal failure, hepatic failure, active gastrointestinal ulcer, myocardial infarction and angina pectoris within 6 months, other uncontrolled disease
6) Diarrhea more than and equal to grade 2
7) Active infection more than and equal to grade 2
8) Massive pleural effusion, peritoneal effusion or cardiac effusion required for tube drainage
9) Symptomatic brain metastasis but eligible for controlled brain metastases
10) Patients required for continuing steroid therapy
11) Pregnant status or lactation
12) Uncontrolled psychiatric disease
13) Other ineligible status judged by medical oncologist.

Target sample size

68


Research contact person

Name of lead principal investigator

1st name Yuichiro
Middle name
Last name Takeda

Organization

National Center for Global health and Medicine

Division name

Department of Respiratory Medicine

Zip code

162-865

Address

1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan

TEL

03-3202-7181

Email

ytakeda@hosp.ncgm.go.jp


Public contact

Name of contact person

1st name Yuichiro
Middle name
Last name Takeda

Organization

National Center for Global health and Medicine

Division name

Department of Respiratory Medicine

Zip code

162-8655

Address

1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan

TEL

03-3202-7181

Homepage URL


Email

ytakeda@hosp.ncgm.go.jp


Sponsor or person

Institute

Department of Respiratory Medicine
National Center for Global health and Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


IRB Contact (For public release)

Organization

Center for Clinical sciences, National Center for Global health and Medicine

Address

1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan

Tel

03-3202-7181

Email

rinrijim@hosp.ncgm.go.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

国立国際医療研究センター病院(東京都)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 31 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

14

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



Progress

Recruitment status

Terminated

Date of protocol fixation

2012 Year 10 Month 17 Day

Date of IRB

2012 Year 10 Month 17 Day

Anticipated trial start date

2012 Year 12 Month 10 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study will terminate at March 31, 2019 because of forced termination based on the clinical study law in Japan.


Management information

Registered date

2013 Year 01 Month 25 Day

Last modified on

2019 Year 03 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011568


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name