UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of S-1 plus Bevacizumab combination chemotherapy for patients with non-small-cell lung cancer.
Title of the study (Brief title)	S-1 plus Bevacizumab combination chemotherapy for patients with non-small-cell lung cancer.
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In this study, S-1 is decided as a combination drug with BEV because it's believed that S-1 become more and more important.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	safety and efficacy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -investigator(s) and assessor(s) are 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	Bevacizumab (Chugai Pharmaceutical Co. Ltd.,: Avastin) S-1 (Taiho pharmaceutical Co. Ltd., TS-1)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with cytological or histological diagnosis of NSCLC except squamous cell carcinoma. Patients who have postoperative recurrence, refractory to one chemotherapy regimen. Preoperative or postoperative adjuvant chemotherapy is not considered as one regimen. Patience with Measurable lesion based on RECIST ver1.1. A lesion within a radiation site is excluded from a measurable lesion. Pleural effusion after pleurodesis is not considered as non-target lesion. Patients who have 4 weeks or more after the prior chemotherapy. If the patient underwent therapy, there should be the following interval between the therapy and the registration. Radiotherapy other than thoracic radiation one week. Radiotherapy including pulmonary field 3 months. Surgery, except CV-port reservation 4 weeks Thoracic drainage two weeks Open biopsy, treatment of injury two weeks Aspiration biopsy, CV-port reservation one week Age: 20 years old or older ECOG Performance Status (PS); 0-2
Key exclusion criteria	Besides the above
Target sample size	55

Research contact person
Name of lead principal investigator	Kenichi Itou
Organization	shinshu University
Division name	surgery 2
Address	Asahi 3-1-1 matumoto
TEL	0263-35-4600
Email	tashiina@shinshu-u.ac.jp

Public contact
Name of contact person	Takayuki Shiina
Organization	shinshu University
Division name	thoracic surgery
Address	Asahi 3-1-1 matumoto
TEL	0263-35-4600
Homepage URL
Email	tashiina@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University thoracic surgery
Institute
Department

Funding Source
Organization	Shinshu University surgery2
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2011 Year 01 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 12 Month 07 Day
Anticipated trial start date	2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 12 Month 07 Day
Last modified on	2017 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005277