UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012805 |
|---|---|
| Receipt number | R000014964 |
| Scientific Title | Feasibility study on the tumorectomy after neoadjuvant chemotherapy in stage IVb endometrial cancer |
| Date of disclosure of the study information | 2014/01/10 |
| Last modified on | 2019/03/05 16:14:18 |
* 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
Feasibility study on the tumorectomy after neoadjuvant chemotherapy in stage IVb endometrial cancer
Acronym
Feasibility study on the tumorectomy after NAC in stage IVb endometrial cancer
Scientific Title
Feasibility study on the tumorectomy after neoadjuvant chemotherapy in stage IVb endometrial cancer
Scientific Title:Acronym
Feasibility study on the tumorectomy after NAC in stage IVb endometrial cancer
Region
| Japan |
Condition
Condition
Stage IVb endometrial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether tumorectomy after NAC in stage IVb endometrial cancer is feasible or not to move onto phase III trial
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
surgical operation ratio
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
neoadjuvant chemotherapy -> surgery -> postoperative chemotherapy
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) Cases with tumor in the endometrium by diagnostic imaging such as CT or MRI and cases with a diagnosis of confirmed endometrial carcinoma such as endometrioid adenocarcinoma, serous adenocarcinoma, clear cell adenocarcinoma or adenosquamous carcinoma by histopathologic examination of endometrium
2) Cases with distant metastasis out of the cavity of lesser pelvis or lymph node metastasis except for regional lymph node and cases with FIGO Stages IVb
3) Patients with no previous treatment such as surgery, chemotherapy or radiation therapy for endometrial cancer
4) Performance status (PS):0-2
5) More than 20 years old and less than 75 years old
6) Adequate bone marrow, cardiac, hepatic and renal functions
7) Patient must have signed informed consent
Key exclusion criteria
1) Cases with a possibility of Primary cancer in other organs such as Cervical cancer or Ovarian cancer by diagnostic imaging
2) Patients with symptoms of brain metastases and bone marrow metastasis
3) Patients with active infection
4) Serious complications (heart disease, uncontrolled diabetes mellitus, malignant hypertension and tendency to bleeding)
5) Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy
6) Patients with any signs of interstitial pneumonia or pulmonary fibrosis by chest radiography
and CT
7) Massive pleural effusion or ascites
8) Neuropathy grade 3 or more (NCI-CTC)
9) Edema grade 3 or more (NCI-CTC)
10) Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil
11) Patients judged inappropriate for this study by the physicians
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Nakanishi, M.D. |
Organization
Tohoku Medical and Pharmaceutical University Hospital
Division name
Department of Gynecology
Zip code
Address
1-12-1- Fukumuro, Miyaginoku, Sendai 983-8512, Japan
TEL
022-259-1221
jgog2046@jgog.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Nakanishi, M.D. |
Organization
JGOG2046 Coordinating Office
Division name
Tohoku Medical and Pharmaceutical University Hospital
Zip code
Address
1-12-1- Fukumuro, Miyaginoku, Sendai 983-8512, Japan
TEL
022-259-1221
Homepage URL
http://www.jgog.gr.jp/
jgog2046@jgog.gr.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Japanese Gynecologic Oncology Group
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
愛知県がんセンター中央病院（愛知県）
中国労災病院独法(広島県）
市立三次中央病院（広島県）
鳥取県立中央病院（鳥取県）
新潟県立がんセンター新潟病院（新潟県）
香川県立中央病院（香川県）
名古屋第二赤十字病院（愛知県）
県立広島病院（広島県）
弘前大学医学部附属病院（青森県）
鹿児島市立病院（鹿児島県）
近畿大学医学部附属病院（大阪府）
横浜市立大学病院（神奈川県）
三沢市立三沢病院（青森県）
東邦大学医療センター大橋病院（東京都）
川崎市立井田病院（神奈川県）
高知医療センター（高知県）
順天堂大学医学部附属順天堂医院（東京都）
慶應義塾大学病院（東京都）
久留米大学病院（福岡県）
愛媛大学医学部附属病院（愛媛県）
癌研有明病院（東京都）
九州がんセンター独法（福岡県）
四国がんセンター独法（愛媛県）
東北大学病院（宮城県）
自治医科大学附属病院（栃木県）
群馬大学医学部附属病院（群馬県）
小倉記念病院（福岡県）
大分大学医学部附属病院（大分県）
京都府立医科大学附属病院（京都府）
埼玉県立がんセンター（埼玉県）
厚生連ＪＡ広島総合病院（広島県）
長崎みなとメディカルセンター（長崎県）
長崎医療センター独法（長崎県）
大阪医科大学附属病院（大阪府）
綜合病院社会保険徳山中央病院（山口県）
姫路赤十字病院（兵庫県）
埼玉医科大学国際医療センター（埼玉県）
三重県立総合医療センター独法（三重県）
防衛医科大学(埼玉県）
岐阜大学医学部附属病院(岐阜県）
琉球大学医学部附属病院(沖縄県）
大阪市立大学医学部附属病院(大阪府）
長崎大学病院(長崎県）
東京医科歯科大学医学部付属病院(東京都）
和泉市立病院(大阪府）
広島市立広島市民病院(広島県）
伊勢赤十字病院(三重県）
大阪府立成人病センター(大阪府）
神戸市立医療センター中央市民病院(兵庫県）
奈良県立病院機構 奈良県総合医療センター(奈良県）
東京慈恵会医科大学附属病院（東京都）
佐賀大学医学部附属病院（佐賀県）
自治医科大学附属病院（栃木県）
半田市立半田病院（愛知県）
東海大学医学部付属病院 (神奈川県）
東京医科大学茨城医療センター（茨城県）
岩手医科大学附属病院（岩手県）
東北医科薬科大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 10 | 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
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 26 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 09 | Day |
Last modified on
| 2019 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014964
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
