UMIN-CTR Clinical Trial

Basic information
Public title	Phase I trial of Bevacizumab and S-1 chemotherapy for patients with previously treated advanced non-small cell lung cancer
Acronym	Bevacizumab and S-1 for previously treated advanced non-small cell lung cancer
Scientific Title	Phase I trial of Bevacizumab and S-1 chemotherapy for patients with previously treated advanced non-small cell lung cancer
Scientific Title:Acronym	Bevacizumab and S-1 for previously treated advanced non-small cell lung cancer
Region	Japan

Condition
Condition	Previously treated non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety of Bevacizumab and S-1
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	safety
Key secondary outcomes	Overall survival, objective response rate , progression free survival

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	bevacizumab and S-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	1) Histologically or cytologically confirmed Stage IIIB/IV non-squamous non-small cell lung cancer 2) Previously treated one or more chemotherapy regimens 3) With one or more measurable disease based on RECIST (ver.1.1) 4) Performance Status (ECOG) : 0-1 5) 20<= years 6) Patients providing written informed consent 7) Adequate function of vital organs, including normal hematopoietic liver and renal function as following: WBC >= 3,000/mm3 or Neutrophils >= 1,500/mm3 Hemoglobin >= 9.0 g/dL Platelets >= 100,000/mm3 AST and ALT, x 2.5 of upper limit of normal (ULN) or less. Total bilirubin <= 1.5mg/mL Serum creatinine <= 1.5mg/dL Creatinin crealance>=30mL/min PT-INR <1.5 Urinary protein <2+ PaO2>=60torr or SpO2>=95% 8)interval: (1) chemotherapy, more than 3 weeks after the last chemotherapy. (2) Radiation, more than 12 weeks after the thoracic irradiation or more than 2 weeks after the last irradiation to other organs. (3) Operation, more than 4 weeks after the last operation (including pleurodesis) 9) A life expectancy of more than 3 months
Key exclusion criteria	1)Interstitial pneumonia or pulmonary fibrosis detectable on X ray. 2)Patients with uncontrollable complications(e.g. uncontrollable heart disease, severe arrhythmia, continuous diarrhea). 3)Patients with active severe infections. 4)History of active double cancer within 5 years prior to the study. 6)Patients with symptomatic brain metastasis 7) 8)History of hemoptysis with 2.5mL or more and Continued bloody phlegm. 9)Pregnancy or lactation 10)evidence of bleeding diathesis or coagulopathy 11)tumor invasive to the chest large blood vessel. Cavity in brain or lung tumor 12)current or previous (within the last 1 year) history of GI perforation 13)current history of uncontrorable hypertension 14)Impossible cases with oral administration. 15)severe drug allergy for 5-FU or UFT or S-1 content medicine 16) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Middle name Last name Makoto Nishio
Organization	Cancer Institute Hospital of Japanese Foudation for Ccancer Research
Division name	Toracic Medical Oncology
Zip code
Address	3-8-31 Ariake Kotoku Tokyo Japan
TEL	03-3520-0111
Email	mnishio@jfcr.or.jp

Public contact
Name of contact person	1st name Middle name Last name Atsushi Horiike
Organization	Cancer Institute Hospital of Japanese Foudation for Ccancer Research
Division name	Toracic Medical Oncology
Zip code
Address	3-8-31 Ariake Kotoku Tokyo Japan
TEL	03-3520-0111
Homepage URL
Email	atsushi.horiike@jfcr.or.jp

Sponsor
Institute	Thoracic Medical Oncology Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department

Funding Source
Organization	Toracic Medical Oncology Cancer Institute Hospital of Japanese Foudation for Ccancer Research
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2012 Year 08 Month 06 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
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	Completed
Date of protocol fixation	2012 Year 07 Month 12 Day
Date of IRB	2012 Year 07 Month 12 Day
Anticipated trial start date	2012 Year 08 Month 10 Day
Last follow-up date	2018 Year 09 Month 05 Day
Date of closure to data entry	2018 Year 09 Month 05 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 08 Month 04 Day
Last modified on	2021 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010123