UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051087 |
|---|---|
| Receipt number | R000057488 |
| Scientific Title | A Phase II study of Gemcitabine, Cisplatin and Bevacizumab for the patients with first recurrent and refractory ovarian clear cell carcinoma |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/03/08 19:30:50 |
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Basic information
Public title
A Phase II study of Gemcitabine, Cisplatin and Bevacizumab for the patients with first recurrent and refractory ovarian clear cell carcinoma
Acronym
KCOG-G2301
Scientific Title
A Phase II study of Gemcitabine, Cisplatin and Bevacizumab for the patients with first recurrent and refractory ovarian clear cell carcinoma
Scientific Title:Acronym
GIANT2 Trial
Region
| Japan |
Condition
Condition
The first-time recurrence/relapse of ovarian cell carcinoma.
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To verify the effictiveness and safety of Gemcitabine + Cisplatin + Bevacizumab combination therapy (GPB) for first-time recurrence/relapse of ovarian cell carcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
PFS(Progression free survival), OS(Overall survival),DCR(disease control rate),AE(Adverse events),Relationship between pathological findings and response
ARID1A,BRCA1/2,ATM,LOH scor,TP53,PIK3CA,MSI,TMB,HR related genes,if NGS was tested.
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
1)Gemcitabine 1000mg/m2 intravenous drip day 1, 15 drip in 30 minutes.
2)Cisplatin 40mg/m2 intravenous drip day 1, 15 drip in 60 minutes.
3)Bevacizumab 10 mg/kg intravenous drip infusion day 1, 15 infused in 90 minutes for the first administration.
If well tolerated, the second dose can be administered in 60 minutes, and the third and subsequent doses can be administered in 30 minutes.
Above, 6 cycles of protocol treatment with 4 weeks as 1 cycle
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) A patient who has histopathologically diagnosed ovarian clear cell carcinoma (including mixed type) and relapsed at the first time after the initial treatment, or patients who relapsed during initial treatment.
2)The initial treatment is a combination of both surgery and chemotherapy or either.
3) The duration from the end of initial treatment to recurrence does not matter (both platinum-sensitive and platinum-resistant patients are eligible).
4) A patient has never been administered gemcitabine for the firstline chemotherapy.
5) A patient has the evaluable lesions.
6) Their age between 20 and 75 years.
7) Performance Status (ECOG) 0 to 2.
8) Laboratory test values within 2 weeks of enrollment satisfy all of the following items.
9) Patients expected to survive for 90 days or more from the start date of registration.
10) Written informed consent has been obtained.
Key exclusion criteria
1)Patients with contraindications to Gemcitabine, Cisplatin or Bevacizumab
2)Patients with uncontrolled heart disease, renal disease, or diabetes
3) Patients with interstitial pneumonia or pulmonary fibrosis (confirmed by CT examination)
4)Patients with intestinal paralysis or intestinal obstruction
5) Patients with infectious diseases requiring treatment
6)Patients who have received radiotherapy to the chest or abdomen
7) Patients with active double cancer (not including carcinoma in situ)
8)Patients with a history of severe drug hypersensitivity
9) Patients with a history of underlying disease associated with obstructive bowel disease including subileus, patients with diverticulum, intestinal fistula, gastrointestinal perforation, intra-abdominal abscess, obvious rectosigmoid colon invasion by pelvic examination, CT examination Patients with clinical symptoms of obvious intestinal infiltration or intestinal obstruction due to
10)Patients with symptomatic central nervous system metastases
11)Patients who are pregnant or breastfeeding, or who may become pregnant during the treatment period of this protocol and are not willing to use contraception
12)Patients with the following diseases
13)Patients who are currently or recently (within 30 days prior to the start of this protocol treatment) receiving or receiving other investigational drugs (including unapproved drugs).
14)Patients who are judged inappropriate for participation in this study by investigators or subinvestigators
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Hori |
Organization
Kansai Rosai Hospital
Division name
Obstetrics and Gynecoplogy
Zip code
6608511
Address
3-1-69, Inabasou, Amagasaki city, Hyogo, Japan
TEL
+81-6-6416-1221
hori-kensuke@kansaih.johas.go.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Hori |
Organization
Kansai Rosai Hospital
Division name
Obstetrics and Gynecology
Zip code
6608511
Address
3-1-69, Inabasou, Amagasaki city, Hyogo, Japan
TEL
+81-6-6416-1221
Homepage URL
https://www.kcog.net/
hori-kensuke@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
Other
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, I
Tel
+81-6-6416-1221
chiken@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
| 2024 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 17 | Day |
Last modified on
| 2024 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057488
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