UMIN-CTR Clinical Trial

Public title

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

Acronym

Phase II of cisplatin and TS1 pulse bevacizumab followed by TS1 and bevacizumab

Scientific Title

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

Scientific Title:Acronym

Phase II of cisplatin and TS1 pulse bevacizumab followed by TS1 and bevacizumab

Region

Japan

Condition

Non-small and non-squamous cell lung cancer

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

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

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

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)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Cisplatin and TS1 pulse bevacizumab followed by TS1 and bevacizumab

the other trial of same chemotherapy without 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

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

I) Eligibility criteria for Pre-registration
1) Histologically or cytologically proven non-squamous and 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 can start within 6 weeks after start of TS1 of last cycle.

Key exclusion criteria

1) Patients with squamous cell lung cancer.
2) History of allergic reaction for agents of present treatment
3) Severe myelosupperssion, renal dysfunction or hepatic dysfunction
4) Patients received post-operation adjuvant therapy within 6 months.
5) Active concomitant malignancy except carcinoma in situ, intramucosal carcinoma or cancer with more than 5 year disease free
6) 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
7) Diarrhea more than and equal to grade 2
8) Active infection more than and equal to grade 2
9) Massive pleural effusion, peritoneal effusion or cardiac effusion required for tube drainage
10) Symptomatic brain metastasis but eligible for controlled brain metastases
11) Patients required for continuing steroid therapy
12) A history of significant hemoptysis (> 2.5 mL red blood per episode) within 3 months before enrolment
13) History of thrombosis
14) Surgical biopsy or treatment within 4 weeks
15) Under treatment of oral coagulant or intravenous coagulant
16) Bleeding tendency, blood coagulation disorder
17) Other ineligible for bevacizumab
18) Pregnant status or lactation
19) Uncontrolled psychiatric disease
20) Other ineligible status judged by medical oncologist.

Target sample size

33

Name of lead principal investigator

1st name
Middle name
Last name	Yuichiro Takeda

Organization

National Center for Global health and Medicine

Division name

Department of Respiratory Medicine

Zip code

Address

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

TEL

03-3202-7181

Email

ytakeda@hosp.ncgm.go.jp

Name of contact person

1st name
Middle name
Last name	Yuichiro Takeda

Organization

National Center for Global health and Medicine

Division name

Department of Respiratory Medicine

Zip code

Address

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

TEL

03-3202-7181

Homepage URL

Email

ytakeda@hosp.ncgm.go.jp

Institute

Department of Respiratory Medicine
National Center for Global health and Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None

Co-sponsor

None

Name of secondary funder(s)

None

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立国際医療研究センター病院（東京都）

Date of disclosure of the study information

2013

Year

01

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

2012

Year

10

Month

17

Day

Date of IRB

Anticipated trial start date

2012

Year

12

Month

17

Day

Last follow-up date

2018

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

01

Month

25

Day

Last modified on

2018

Year

09

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011567