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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025399
Receipt No. R000028865
Scientific Title Randomized phase III trial to confirm the superiority of pelvic and para-aortic lymphadenectomy for patients with endometrial cancer(JCOG1412, SEPAL-P3)
Date of disclosure of the study information 2016/12/26
Last modified on 2016/12/26

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Basic information
Public title Randomized phase III trial to confirm the superiority of pelvic and para-aortic lymphadenectomy for patients with endometrial cancer(JCOG1412, SEPAL-P3)
Acronym Randomized phase III trial to confirm the superiority of pelvic and para-aortic lymphadenectomy for patients with endometrial cancer(JCOG1412, SEPAL-P3)
Scientific Title Randomized phase III trial to confirm the superiority of pelvic and para-aortic lymphadenectomy for patients with endometrial cancer(JCOG1412, SEPAL-P3)
Scientific Title:Acronym Randomized phase III trial to confirm the superiority of pelvic and para-aortic lymphadenectomy for patients with endometrial cancer(JCOG1412, SEPAL-P3)
Region
Japan

Condition
Condition endometrial cancer with preoperative rsik of lymph node metastasis (preoperative stage IB-IIIC1)
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the superiority of pelvic and para-aortic lymphadenectomy compared with pelvic lymphadenectomy alone for preoperative stage IB through IIIC1 of endometrial cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes overall survival
Key secondary outcomes relapse-free survival, blood loss, operation time, bllod transfusion, surgery-related complications, adverse events ralated to chemotherapy, recurrence pattern (site)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
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 Maneuver
Interventions/Control_1 A: total abdominal hysterectmy+bilateral salpingo-oophorectomy+pelvic lymphadenectomy
Interventions/Control_2 B: total abdominal hysterectmy+bilateral salpingo-oophorectomy+pelvic lymphadenectomy+para-aortic lymphadenectomy
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 1st inclusion criteria (before surgery)
1. Histologically diagnosed endometrial carcinoma (endometrioid, mucinous, serous, clear cell, undifferentiated, mixed)
2. Preoperative IB, II, IIIA, IIIB, IIIC
Patients with preoperative stage IIIC must fulfill both i) and ii) diagnosed by enhanced CT
i) No para-aortic lymph node (PAN) swelling and no multiple pelvic lymph node (PLN) swelling ii) PAN swelling or multiple PLN swelling with negative PET
Lymph node swelling is defined as a node with 10mm or more of minor axis
3. No peritoneal dissemination, no distant metastasis, and no inguinal node metastasis by enhanced CT
4. No bladder invasion, no rectum invasion by enhanced MRI
5. 20-75 years old
6. ECOG performance status of 0 or 1
7. Body mass index<=35
8. No prior surgery for gastrointestinal tract (appendectomy is allowed)
9. No prior treatment with irradiation or chemotherapy for any malignancies
(exclude history of breast cancer with 5-year disease-free)
10. Adequate organ functions
i. WBC>= 3,000/mm3
ii. Platelet >= 100,000/mm3
iii. T.Bil <= 1.5 mg/dL
iv. AST <= 100 IU/L
v. ALT <= 100 IU/L
vi. Creatinine <= 1.5 mg/dL
11. Written informed consent
2nd inclusion criteria (during surgery)
1. Not suspicious for para-aortic node metastasis by inspection and palpation.
In case of suspicious para-aortic node metastasis, negative result by frozen section diagnosis
2. Not suspicious for node metastases of multiple pelvic regions by inspection and palpation.
In case of suspicious node metastases of multiple pelvic regions, all nodes are negative or only one region of pelvic node metastasis is allowed by frozen section diagnosis.
3. Not suspicious for peritoneal dissemination by inspection and palpation
In case of suspicious peritoneal dissemination, negative result by frozen section diagnosis
4. Neither suspicious for bladder invasion nor rectum invasion
Key exclusion criteria 1. Simultaneous or metachronous (within 5 years) double cancers except carcinoma in situ or intramucosal tumor
2. Active systemic infections to be treated
3. Body temperature of 38 degrees Celsius or higher
4. Women during pregnancy, possible pregnancy, postpartum within 28 days or breast-feeding
5. Psychiatric disease
6. Currently treated with continuous systemic steroid, immunosuppressive agents
7. Uncontrolled diabetes mellitus or routine administration of insulin
8. Currently treated with continuous anticoagulant drug/antiplatelet agent
9. Uncontrolled hypertension
10. History of cardiac failure, unstable angina or prior myocardial infarction within 6 months
11. HBs antigen positive
12. HIV antibody positive
13. Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema
14. Hypersensitivity to polyoxyethylated castor oil or hydrogenated castor oil
15. Hypersensitivity to alcohol
Target sample size 800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriaki Sakuragi
Organization Hokkaido University Graduate School of Medicine
Division name Department of Reproductive Endocrinology and Oncology
Zip code
Address West7, North15, kita-ku, Sapporo, 060-8638, JAPAN
TEL 011-706-5941
Email sakuragi@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidemichi Watari
Organization JCOG1412 Coordinating Office
Division name Department of Gynecology, Hokkaido University Hospital
Zip code
Address West7, North15, kita-ku, Sapporo, 060-8638, JAPAN
TEL 011-706-5941
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 北海道大学病院(北海道)
札幌医科大学(北海道)
岩手医科大学(岩手県)
東北大学病院(宮城県)
茨城県立中央病院・茨城県地域がんセンター(茨城県)
筑波大学医学医療系(茨城県)
群馬県立がんセンター(群馬県)
防衛医科大学校(埼玉県)
埼玉県立がんセンター(埼玉県)
埼玉医科大学総合医療センター(埼玉県)
東京慈恵会医科大学附属柏病院(千葉県)
国立がん研究センター中央病院(東京都)
がん・感染症センター都立駒込病院(東京都)
東京女子医科大学(東京都)
慶應義塾大学病院(東京都)
東京慈恵会医科大学附属病院(東京都)
がん研究会有明病院(東京都)
東京大学医学部(東京都)
順天堂大学医学部附属順天堂医院(東京都)
NTT東日本関東病院(東京都)
北里大学医学部(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
新潟大学医歯学総合病院(新潟県)
信州大学医学部(長野県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
名古屋大学医学部(愛知県)
京都大学医学部附属病院(京都府)
大阪市立大学医学部附属病院(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
大阪市立総合医療センター(大阪府)
大阪医科大学(大阪府)
兵庫県立がんセンター(兵庫県)
鳥取大学医学部(鳥取県)
国立病院機構呉医療センター・中国がんセンター(広島県)
国立病院機構四国がんセンター(愛媛県)
国立病院機構九州がんセンター(福岡県)
久留米大学医学部(福岡県)
九州大学病院(福岡県)
佐賀大学医学部(佐賀県)
熊本大学医学部(熊本県)
鹿児島大学医学部・歯学部附属病院(鹿児島県)
鹿児島市立病院(鹿児島県)
琉球大学医学部附属病院(沖縄県)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 26 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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 26 Day
Last follow-up date
2027 Year 06 Month 26 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 12 Month 26 Day
Last modified on
2016 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028865

Research Plan
Registered date File name

Research case data specifications
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Research case data
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