UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008481 |
|---|---|
| Receipt number | R000009225 |
| Scientific Title | Randomized Phase III Trial of the need for adjuvant chemotherapy in stage I epithelial ovarian cancer after comprehensive staging surgery |
| Date of disclosure of the study information | 2012/07/20 |
| Last modified on | 2024/11/15 15:18:41 |
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Basic information
Public title
Randomized Phase III Trial of the need for adjuvant chemotherapy in stage I epithelial ovarian cancer after comprehensive staging surgery
Acronym
Randomized Trial of the need for adjuvant chemotherapy in stage I epithelial ovarian cancer
Scientific Title
Randomized Phase III Trial of the need for adjuvant chemotherapy in stage I epithelial ovarian cancer after comprehensive staging surgery
Scientific Title:Acronym
Randomized Trial of the need for adjuvant chemotherapy in stage I epithelial ovarian cancer
Region
| Japan | Asia(except Japan) |
Condition
Condition
Stage I epithelial ovarian cancer after comprehensive staging surgery
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to evaluate the need for platinum-based chemotherapy as adjuvant chemotherapy through comparison using Disease-specific Survival(DSS)for subjects diagnosed with FIGO stage I epithelial ovarian cancer after comprehensive staging surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Disease-specific Survival (DSS)
Key secondary outcomes
Overall survival (OS)
Relapse free survival (RFS)
Incidence rate of adverse events in the adjuvant chemotherapy group
Incidence rate of postoperative complications (early and late stage)
Treatment (including surgery) or no treatment for complications
Incidence rate of second cancers
Relationship between prognosis and the following items (subset analysis)
Planned chemotherapy cycles
Histologic type
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
combination of paclitaxel and carboplatin
Interventions/Control_2
Observation
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
| Not applicable |
Gender
Female
Key inclusion criteria
1) Patients with a diagnosis of histopathologically epithelial ovarian cancer
2) FIGO Stages IA(Grade2/3, clear cell carcinoma), IB(Grade2/3, clear cell carcinoma) and IC1(all degree of differentiation and all histologic type)
3) Patients with a diagnosis of advanced stage by comprehensive staging or restaging laparotomy.
4) Patients who received comprehensive staging surgery (basic surgical techniques (total hysterectomy, bilateral salpingo-oophorectomy, and omentectomy) as well as peritoneal cytology, multiple biopsies of the peritoneum ([Peritoneal biopsy] see details below), retroperitoneal lymph node dissection (see details below [Retroperitoneal lymph node dissection]).
However, for the following cases, it is eligible as a condition to record on the official document.
* Peritoneal biopsy: peritoneal metastasis is not recognized by macroscopic and palpation in the stipulated site, and the case that biopsy has not been performed.
* Retroperitoneal lymph node dissection: the case that lymph nodes of the stipulated range has been dissected however the prescribed number has not been reached.
5) Age: 20 or older
6) Performance status (PS):0-1
7) Case with initial therapy for postoperative primary lesion
8) Patient possible to receive the first study treatment within 8 weeks after the comprehensive staging surgery
9) Reasonable organ function
10) Patient must have signed informed consent.
Key exclusion criteria
1) FIGO Stages IC2, IC3
2) Patients containing sarcoma elements
3) Patients with any signs of interstitial pneumonia or pulmonary fibrosis by chest radiography
and CT
4) Patients with serious complications
5) Patients with active infection
6) Patients with intestinal paralysis or intestinal obstruction
7) Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy
8) Patients with previous chemotherapy or radiation therapy
9) Patients with serious drug hypersensitivity
10) Patients with peripheral motor/sensory neuropathy (grade2,3,4 CTC-AE 4.0)
11) Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil
12) Patients with positive HBsAg.Patients with more than 2.1 log/copies ml based on fixed HBV-DNA who are positive with either antigen-positive HBs, anti-hepatitis B core antigen or anti-hepatitis B surface antigen.
13) Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Tanabe |
Organization
National Cancer Center Hospital East
Division name
Department of gynecology
Zip code
277-8577
Address
Kashiwanoha 6-5-1, Kashiwa-shi, Chiba, 277-8577 Japan
TEL
04-7133-1111
jgog3020@jgog.gr.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Tanabe |
Organization
JGOG3020 Coordinating Office
Division name
National Cancer Center Hospital East ,gynecology
Zip code
277-8577
Address
Kashiwanoha 6-5-1, Kashiwa-shi, Chiba, 277-8577 Japan
TEL
04-7133-1111
Homepage URL
http://www.jgog.gr.jp/
jgog3020@jgog.gr.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital East
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japanese Gynecologic Oncology Group
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital East Certified Review Board
Address
6-5-1 Kashiwanoha, Kashiwa-shiChiba-ken, 277-8577 Japan
Tel
04-7133-1111
ncche-irb@east.ncc.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
東京慈恵会医科大学附属柏病院（千葉県）
東海大学医学部付属病院（神奈川県）
弘前大学医学部附属病院（青森県）
東京慈恵会医科大学附属病院（東京都）
東京慈恵会医科大学附属葛飾医療センター（東京都）
四国がんセンター独法（愛媛県）
自治医科大学附属病院(栃木県）
埼玉医科大学国際医療センター(埼玉県）
岩手医科大学附属病院（岩手県）
兵庫県立がんセンター（兵庫県）
鳥取大学医学部附属病院（鳥取県）
横浜市立市民病院（神奈川県）
藤田医科大学病院（愛知県）
慶應義塾大学病院（東京都）
久留米大学病院（福岡県）
愛知県がんセンター（愛知県）
関西ろうさい病院独法（兵庫県）
琉球大学病院（沖縄県）
神戸市立医療センター中央市民病院（兵庫県）
東京慈恵会医科大学附属第三病院（東京都）
筑波大学附属病院（茨城県）
がん・感染症センター都立駒込病院（東京都）
大阪医科大学病院（大阪府）
山形大学医学部附属病院（山形県）
がん研究会有明病院（東京都）
東京科学大学病院（東京都）
九州大学病院（福岡県）
静岡県立静岡がんセンター（静岡県）
近畿大学病院（大阪府）
厚生連ＪＡ広島総合病院（広島県）
愛媛大学医学部附属病院（愛媛県）
東京大学医学部附属病院（東京都）
鹿児島大学病院(鹿児島県）
広島市立広島市民病院(広島県）
東京都立多摩総合医療センター（東京都）
新潟県立がんセンター新潟病院(新潟県）
獨協医科大学埼玉医療センター(埼玉県)
新潟大学医歯学総合病院(新潟県)
信州大学医学部附属病院(長野県)
獨協医科大学病院(栃木県)
三重大学病院(三重県)
済生会長崎病院(長崎県)
横浜市立大学附属病院(神奈川県)
埼玉病院(埼玉県)
東京女子医科大学附属足立医療センター（東京都）
佐々木研究所附属杏雲堂病院（東京都）
Seoul ST' Mary's Hospital（Korea）
National Cancer Center（Korea)
Kangbuk Samsung Hospital（Korea)
Severance Hospital（Korea）
Gachon University Gil Medical Center（Korea）
国立がん研究センター東病院（千葉県）
神戸大学医学部附属病院（兵庫県）
Gangnam Severance Hospital（Korea）
Obstetrics and Gynecology Hospital（Shanghai）
Zhongshan Hospital（Shanghai）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
300
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
| 2012 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2029 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2029 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2030 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 20 | Day |
Last modified on
| 2024 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009225
