UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059243 |
|---|---|
| Receipt number | R000067688 |
| Scientific Title | Prospective cohort study of Paclitaxel plus Carboplatin plus Bevacizumab Therapy as First Line Chemotherapy for Advanced Ovarian Clear cell Carcinoma |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/30 14:45:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective cohort study of Paclitaxel plus Carboplatin plus Bevacizumab Therapy as First Line Chemotherapy for Advanced Ovarian Clear cell Carcinoma
Acronym
Prospective cohort study of Paclitaxel plus Carboplatin plus Bevacizumab Therapy as First Line Chemotherapy for Advanced Ovarian Clear cell Carcinoma
Scientific Title
Prospective cohort study of Paclitaxel plus Carboplatin plus Bevacizumab Therapy as First Line Chemotherapy for Advanced Ovarian Clear cell Carcinoma
Scientific Title:Acronym
JGOG3033
Region
| Japan |
Condition
Condition
Advanced ovarian clear cell carcinoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigate the efficacy and safety of the combination chemotherapy of paclitaxal, carboplarin and bevacizumab in patients with advanced ovarian clear cell carcinoma (stage III/IV).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
progression-free survaival
Key secondary outcomes
Overall survival, survival rate, response rate, adverse effects
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Patients with newly diagnosed, histologically confirmed ovarian clear cell carcinoma, FIGO stage III - IV. All patients underwent appropriate surgical procedures, including diagnostic laparoscopy, to obtain tissue for histopathological confirmation of ovarian clear cell carcinoma. In cases with mixed histology, clear cell carcinoma accounted for the predominant component (>50%). A central pathological review was not performed. Immunohistochemical evaluation for WT1 (negative), p53 (negative), and Napsin A (positive) was performed for confirmation, although it was not required.
2. Patients scheduled to receive combination chemotherapy with paclitaxel and carboplatin plus bevacizumab, who have provided informed consent for treatment. In cases where bevacizumab is contraindicated, up to two cycles of paclitaxel - carboplatin chemotherapy without bevacizumab are permitted. Patients who do not receive bevacizumab within three cycles will be excluded from the primary analysis of this study.
3. Patients aged 18 years or older.
4. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
5. Patients with adequate organ function.
6. Patients who have provided written informed consent to participate in this clinical trial.
7. Patients who are able to initiate chemotherapy within 6 weeks after primary surgery.
Key exclusion criteria
1. Patients with contraindications specific to bevacizumab, including active pulmonary hemorrhage, cerebral hemorrhage, congenital bleeding diathesis, coagulation disorders, a history of cerebral infarction, active deep vein thrombosis (DVT), pulmonary embolism (PE), uncontrolled hypertension (>= grade 3), or proteinuria (>= grade 3, urine protein-to-creatinine ratio [UPC] >= 3.5).
Active DVT or PE is defined as symptomatic thrombosis or non-organized thrombosis under anticoagulation therapy (i.e., cases not controlled with anticoagulation).
2. Patients who are scheduled to receive PARP inhibitors alone as maintenance therapy following first-line chemotherapy.
3. Patients with a history of obstructive bowel disease, including subileus, or underlying conditions such as diverticulitis, enteric fistula, gastrointestinal perforation, or intra-abdominal abscess; patients with evident rectosigmoid invasion on pelvic examination; or patients with radiologically confirmed bowel invasion or clinical symptoms of bowel obstruction on CT imaging.
Patients in whom the invasive lesion involving the rectosigmoid or other bowel sites has been surgically resected are eligible.
4. Patients with a history of hypersensitivity to any agents used in combination with bevacizumab.
5. Patients with a history of abdominal radiotherapy.
6. Patients with a history of hemoptysis (>= 2.5 mL of fresh blood).
7. Patients with severe infections at the time of enrollment.
8. Patients deemed by the investigator to be unsuitable for participation in this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Tate |
Organization
Japanese Gynecologic Oncology Group
Division name
Japanese Gynecologic Oncology Group
Zip code
162-0825
Address
4F, Komatsu Building, 6-22 Kagurazaka, Shinjuku-ku, Tokyo, Japan
TEL
03-5206-1982
info@jgog.gr.jp
Public contact
Name of contact person
| 1st name | S |
| Middle name | |
| Last name | Tate |
Organization
Japanese Gynecologic Oncology Group
Division name
Japanese Gynecologic Oncology Group
Zip code
162-0825
Address
4F, Komatsu Building, 6-22 Kagurazaka, Shinjuku-ku, Tokyo, Japan
TEL
03-5206-1982
Homepage URL
info@jgog.gr.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Tohoku University Hospital Institutional Review Board
Address
1-1 Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi, Japan
Tel
022-717-7251
muneaki.shimada.b7@tohoku.ac.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
| 2025 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Age
Performance Status (PS)
Germline BRCA pathogenic variant
HRD testing
Ovarian cancer clinical information
Immunohistochemistry (IHC)
Thrombosis
Use of anticoagulation therapy (Yes/No)
Tumor markers
Assessment of ascites on CT
Neoadjuvant chemotherapy
Primary surgery / Primary debulking surgery (PDS)
Adjuvant chemotherapy
PARP inhibitor administration
(PAOLA regimen)
Response assessment under the PAOLA regimen
Details of first recurrence
Treatment at first recurrence
Cancer gene panel testing / Comprehensive genomic profiling (CGP)
Postoperative complications after cytoreductive surgery
Bevacizumab adverse events
Occurrence of second primary malignancies
Management information
Registered date
| 2025 | Year | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067688
