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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023097
Receipt No. R000026621
Scientific Title A phase 2 trial of Gemcitabine+Cisplatin+Bevacizumab regimen for the patients with first recurrence or refractory of ovarian clear cell carcinoma KCOG-G1601
Date of disclosure of the study information 2016/07/11
Last modified on 2020/01/14

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Basic information
Public title A phase 2 trial of Gemcitabine+Cisplatin+Bevacizumab regimen for the patients with first recurrence or refractory of ovarian clear cell carcinoma KCOG-G1601
Acronym A phase 2 trial of Gemcitabine+Cisplatin+Bevacizumab regimen for the patients with first recurrence or refractory of ovarian clear cell carcinoma KCOG-G1601
Scientific Title A phase 2 trial of Gemcitabine+Cisplatin+Bevacizumab regimen for the patients with first recurrence or refractory of ovarian clear cell carcinoma KCOG-G1601
Scientific Title:Acronym A phase 2 trial of Gemcitabine+Cisplatin+Bevacizumab regimen for the patients with first recurrence or refractory of ovarian clear cell carcinoma KCOG-G1601
Region
Japan

Condition
Condition first recurrent or refractory of ovarian clear cell carcinoma
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess efficacy and safety of GPB regimen for the first recurrence or refractory of ovarian clear cell carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression free survival,Overall survival,Disease control rate,Adverse events,Relationship between pathological findings and response

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 Gemcitabine 1000mg per m2 day1,15
Cisplatin 40mg per m2 day1,15
q4w 6cycles maximum 10 cycles

Bevacizumab 15 mg per kg day1
q3w 8cycles maximum 13 cycles
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
75 years-old >=
Gender Female
Key inclusion criteria 1)Histologically confirmed ovarian clear cell carcinoma,included mixed type,recurrence or refractory after or during first treatment
2)First treatment-operation only,chemotherapy only,operation with chemotherapy
3)There is no limitation of interval of recurrence-Pt sensitive,Pt resistant and refractory are eligible
4)No use of gemcitabine for first treatment
5)Measurable disease
6)Age 20 to 75 years old
7)PS 0 to 2
8)Labo data within two weeks prior to entry satisfy following criteria
1.neutro>=1500mm3
2.platelet>=10*104/mm3
3.Hb>=9.0/dl transfusion available
4.T-Bil<=1.5mg/dl
5.AST and ALT<=100IU/l
6.serum creatinine<=1.5mg/dl
7.eGFR>=50ml/min/1.73m2
8.PT-INR<=1.5 If patient takes warfarin,1.5<=PT-INR<=2.5
9.Urine protein<=1+ If urine protein=2+, confirm urine protein <=1.0g/day in urine collection
9)Patient who is expected to be alive more than 90 days
10)Written informed consent
Key exclusion criteria 1)Patient is contraincicated for use in gemcitabine,cisplatin and bevacizumab
2)Patient with uncontrolled heart disease,renal disease and diabetes mellitus
3)Patient with interstitial pneumonia or lung fibrosis
4)Patient with paresis of intestine or ileus
5)Patient with active infection
6)Patient who had chest and abdominal radiation therapy prior to registration
7)Patient with active other malignancy,excluded carcinoma in situ
8)Patient with history of severe drug allergy
9)Patient with obstructive bowel disease,diverticular perforation,intestinal fistula,perforation of the digestive tract,intraperitoneal abscess and Patient with intestinal invasion or ileus confirmed by pelvic examination or CT
10)Patient who have central nerve metastasis with symptom
11)Patient with pregnancy or breast-feeding,Patient who has possibility of pregnancy,notwilling to contraception
12)the following patient
1.Patient with arterial thrombosis or venous thrombosis,included cerebrovascular disorder,stroke,transient ischemic attack or subarachnoid bleeding within 6 months prior to this treatment,but history of arterial thrombosis or venous thrombosis,if control is good,registration is possible.
2.Patient who meets definition of NYHA 2 or has history of myocardial infarction,unstable angina or congestive heart failure
3.Patient with sever arrhythmia who needed medication,excluded atrial fibrillation or paroxysmal supraventricular tachycardia
4.Patient with uncontrolled hypertension(BPs>=150mmHg or BPd>=100mmHg irrespective of treatment)
5.Unhealed wound,ulcer and fracture
6.Patient with positive HBs antigen,HBc antibody or HBs antibody and HPV-DNA>=2.1 log copies/ml
7.HIV infection
13)Patient who received other test drug within 30 days prior to this treatment
14)Attending physician decides to entry inappropriate
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kimihiko
Middle name
Last name Ito
Organization Kansai Rosai Hospital
Division name Obstetrics and gynecology
Zip code 6608511
Address 3-1-69 Inabaso Amagasaki city Hyogo prefecture
TEL 06-6416-1221
Email ito-kimihiko@kansaih.johas.go.jp

Public contact
Name of contact person
1st name Kimihiko
Middle name
Last name Ito
Organization Kansai Rosai Hospital
Division name Obstetrics and gynecology
Zip code 6608511
Address 3-1-69 Inabaso Amagasaki city Hyogo prefecture
TEL 06-6416-1221
Homepage URL
Email ito-kimihiko@kansaih.johas.go.jp

Sponsor
Institute Kansai clinical oncology group(KCOG)
Institute
Department

Funding Source
Organization Kansai clinical oncology group(KCOG)
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 Kansai Rosai Hospital
Address 3-1-69 Inabaso Amagasaki city Hyogo prefecture
Tel 0664161221
Email ito-kimihiko@kansaih.johas.go.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
2016 Year 07 Month 11 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 18
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 No longer recruiting
Date of protocol fixation
2016 Year 05 Month 19 Day
Date of IRB
2016 Year 06 Month 28 Day
Anticipated trial start date
2016 Year 07 Month 11 Day
Last follow-up date
2020 Year 12 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
2016 Year 07 Month 10 Day
Last modified on
2020 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026621

Research Plan
Registered date File name
2019/11/28 GIANT プロトコル 2.0版 (2019.2.15).pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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