UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023097 |
|---|---|
| Receipt number | 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 | 2022/12/22 13:23:50 |
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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
| Obstetrics 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
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
ito-kimihiko@kansaih.johas.go.jp
Sponsor or person
Institute
Kansai clinical oncology group(KCOG)
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://journals.lww.com/anti-cancerdrugs/Abstract/9900/Phase_II_study_of_gemcitabine,_cisplatin,_an
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
| 2022 | Year | 12 | Month | 05 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2021 | 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
| 2022 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.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 |
