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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032671
Receipt No. R000037132
Scientific Title Phase Ib study of combination therapy with Cisplatin, Irinotecan, and Ramucirumab for extensive-disease small-cell lung cancer
Date of disclosure of the study information 2018/05/22
Last modified on 2018/11/21

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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 C elsius
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 (SBP>=150 or DBP >= 90 mmHg)
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)Myocardial infarction, unstable angina pectoris, cerebrovascular accident, or TIA within 6 months. Any events caused by arterial thromboembolism within 6 months.
15)Regular use of NSAIDS, antiplatelet drug, warfarin. Aspirin less than 325mg per day is acceptable.
16)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
17)Serious hypersensitivity against platinum-based drugs or irinotecan
18)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.
19)Interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
20)Positive HBs antigen
21)Pregnant or lactating women or women willing child-bearing
22)Psychiatric disease
23)The investigator judged ineligible with any reason.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Takahashi
Organization Shizuoka Cancer Center
Division name Division of Thoracic Oncology
Zip code
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
Middle name
Last name Hirotsugu Kenmotsu
Organization Shizuoka Cancer Center
Division name Division of Thoracic Oncology
Zip code
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
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
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
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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 23 Day
Last follow-up date
2020 Year 05 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
2018 Year 11 Month 21 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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