UMIN-CTR Clinical Trial

Basic information
Public title	Phase Ib study of combination therapy with Cisplatin, Irinotecan, and Ramucirumab for extensive-disease small-cell lung cancer
Acronym	Phase Ib study for SCLC (CIRCLE study)
Scientific Title	Phase Ib study of combination therapy with Cisplatin, Irinotecan, and Ramucirumab for extensive-disease small-cell lung cancer
Scientific Title:Acronym	Phase Ib study for SCLC (CIRCLE study)
Region	Japan

Condition
Condition	Extensive disease small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Phase Ib study of combination therapy with cisplatin, irinotecan, and ramucirumab for extensive-disease small-cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Incidence rate of dose-limiting toxicities
Key secondary outcomes	Response rate, progression-free survival, overall survival, and incidence rate of adverse events

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, Irinotecan, Ramucirumab
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	74 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Cytologically or histologically confirmed SCLC . 2)Extensive disease 3)Aged 20 to 74 years old 4)ECOG Performance Status 0 or 1 5)No prior chemotherapy for SCLC; however,Patient with postoperative adjuvant chemotherapy history is eligible after more than 6 months. 6)Patients who have not received thoracic radiotherapy with radiation field within the thorax (the lung field and mediastinum). 7)Presence of measurable disease based on RECIST v.1.1; however, irradiated sites are excluded from measurable sites. 8)More than 14 days after the end of palliative radiotherapy in organs other than the chest (the same day of the week can be accepted). 9)Adequate organ functions 10)Life expectancy > 12 weeks. 11)Diarrhea and intestinal obstruction. 12)The patient has resolution to Grade <=1 by CTCAE v.4.0, of any toxic effects of prior anticancer therapy. 13)Women willing not to have children. For women of childbearing potential, serum or urine pregnancy test result during the 7 days prior to the registration must be negative. 14)Written informed consent
Key exclusion criteria	1)Symptomatic brain metastases 2)Major surgery within 28 days or have subcutaneous venous access device placement within 7 days, prior to registration 3)Active infection requiring systemic treatment 4)Body temperature >= 38 degrees Celsius 5)Congestive heart failure with NYHA Class II to IV, or symptomatic, uncontrollable arrhythmia 6)Cirrhosis with Child-Pugh classification B score or more severe, or hepatic encephalopathy history 7)Poorly controlled hypertension 8)Hemoptysis history, more than one-half teaspoonful, within 2 months 9)Vasculitis, grade 3 or above gastrointestinal hemorrhage, or clinically serious hemorrhage within 3 months 10)Gastrointestinal/bowel perforation, gastric ulcer, diverticulum, or fistula within 6 months 11)Poor wound healing or bone fracture within 28 days 12)Radiographic major blood vessel invasion or encasement by cancer 13)Radiographic intratumoral cavitation 14)Active double cancer 15)Myocardial infarction, unstable angina pectoris, cerebrovascular accident, or TIA within 6 months. Any events caused by arterial thromboembolism within 6 months. 16)Receiving long-term treatment of NSAIDS, antiplatelet drug within 7 days before the initial administration of the study drug. Aspirin less than 325mg per day is acceptable. 17)Participant of other clinical studies with other drugs, unapproved drugs and medical devices, or clinical studies that are considered scientifically or medically incompatible with this study 18)Serious hypersensitivity against platinum-based drugs or irinotecan 19)Continuous systemic administration of high-dose steroids equivalent to prednisolone >= 10 mg/day (oral or intravenous), immunosuppressants. Patients who are taking oral steroids equivalent to prednisolone <10 mg/day are acceptable. 20)Interstitial pneumonia, pulmonary fibrosis or severe emphysema 21)Positive HBs antigen 22)Pregnant or lactating women or women willing child-bearing 23)Psychiatric disease 24)The investigator judged ineligible with any reason
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Toshiaki Middle name Last name Takahashi
Organization	Shizuoka Cancer Center
Division name	Division of Thoracic Oncology
Zip code	411-8777
Address	1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan
TEL	055-989-5222
Email	circle@scchr.jp

Public contact
Name of contact person	1st name Hirotsugu Middle name Last name Kenmotsu
Organization	Shizuoka Cancer Center
Division name	Division of Thoracic Oncology
Zip code	411-8777
Address	1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan
TEL	055-989-5222
Homepage URL
Email	circle@scchr.jp

Sponsor
Institute	Shizuoka Cancer Center
Institute
Department

Funding Source
Organization	Eli Lilly Japan K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shizuoka Cancer Center Institutional Review Board
Address	1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan
Tel	055-989-5222
Email	rinsho_office@scchr.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

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 22 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	10
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	2018 Year 04 Month 12 Day
Date of IRB	2017 Year 12 Month 15 Day
Anticipated trial start date	2018 Year 05 Month 23 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 05 Month 22 Day
Last modified on	2021 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037132