UMIN-CTR Clinical Trial

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

endometrial cancer with preoperative rsik of lymph node metastasis (preoperative stage IB-IIIC1)

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2016

Year

12

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

12

Month

26

Day

Last modified on

2016

Year

12

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028865