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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017628
Receipt No. R000020026
Scientific Title A phase III study of minimally invasive versus open esophagectomy for thoracic esophageal cancer (JCOG1409, MONET trial)
Date of disclosure of the study information 2015/05/20
Last modified on 2015/05/20

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Basic information
Public title A phase III study of minimally invasive versus open esophagectomy for thoracic esophageal cancer (JCOG1409, MONET trial)
Acronym A phase III study of minimally invasive versus open esophagectomy for thoracic esophageal cancer (JCOG1409, MONET trial)
Scientific Title A phase III study of minimally invasive versus open esophagectomy for thoracic esophageal cancer (JCOG1409, MONET trial)
Scientific Title:Acronym A phase III study of minimally invasive versus open esophagectomy for thoracic esophageal cancer (JCOG1409, MONET trial)
Region
Japan

Condition
Condition clinical stage I/II/III (excluding T4) thoracic esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To confirm the non-inferiority of thoracosopic esophagectomy (minimally invasive esophagectomy) to open esophagectomy for clinical stage I-III esophageal cancer patients.
Basic objectives2 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, proportion of patients with R0 resection, proportion of patients who needed re-operation, adverse events, postoperative respiratory function, postoperative quality of life (EORTC QLQ-C30), proportion of patients who underwent conversion from thoracoscopic surgery to open surgery

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
Maneuver
Interventions/Control_1 A:
Thoracic approach; open esophagectomy via a right thoracotomy in the lateral decubitus position.
Abdominal approach; open or laparoscopic approach
D2 or more lymph node dissection is performed.
Interventions/Control_2 B:
Thoracic approach; thoracoscopic esophagectomy via a right thoracoscopy in the lateral decubitus position or prone position.
Abdominal approach; open or laparoscopic approach
D2 or more lymph node dissection is performed.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Staging of tumor is performed according to the UICC/AJCC 7th edition of the TNM Classification of Malignant Tumours.
To be eligible for this study, patients must fulfill all of the following criteria:
1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma or basaloid cell carcinoma.
2) Primary tumor located in thoracic esophagus. Tumor which is centrally located more than 2 cm below of the esophago-gastric junction is ineligible
3) Either single lesion or multiple lesions. Second tumors in cervical esophagus which is indicated for EMR/ESD are also eligible.
4) Clinical stages I, II or III (excluding T4) based on the 7th UICC-TNM classification. Patients who received preoperative chemotherapy must fulfil both i) and ii).
i) Clinical stage before chemotherapy is I, II or III (excluding T4)
ii) No T4 lesions or metastatic lesions are observed after chemotherapy.
5) Aged 20 to 80 years.
6) PS (ECOG) of 0 or 1.
7) No prior treatment against esophageal cancer except for i)-iii)
i) Non-curative resection for primary tumor by EMR/ESD.
ii) Clinical stage IB, II or III esophageal cancer patients who received 2 courses or less of cisplatin plus fluorouracil.
iii) Curative resection had been achieved by EMR/ESD against metachronous multiple cancer.
8) No prior treatment of chemotherapy or radiation therapy against any other malignancies. History of adjuvant hormonal therapy after more than 1 year from the last administration is eligible
9) No prior lateral thoracotomy (or thoracoscopic surgery) on right side or no prior lobectomy or more extended surgery on left side was performed.
10) Pre-operative FEV1.0 > 1000 ml
11) Sufficient organ functions.
i. WBC >= 3,000/mm3
ii. Platelet >= 100,000/mm3
iii. Hemoglobin >=10mgldL
iv. T.Bil =< 1.5 mg/dL
v. AST =< 100 IU/L
vi. ALT =< 100 IU/L
vii. Creatinine =< 1.5 mg/dL
viii. SpO2 >= 95%
12) R0 esophagectomy is expected.
13) Written informed consent.
Key exclusion criteria 1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
2) Infectious disease with systemic therapy indicated.
3) Body temperature of 38 or more degrees Celsius.
4) Pregnancy, possible pregnancy, within 28 days after delivery or breast-feeding.
5) Severe psychiatric disease.
6) Continuous systemic steroid or immune-suppressive drug therapy.
7) Unstable angina pectoris, or history of myocardial infarction within six months.
8) Severe pulmonary fibrosis or emphysema.
9) Poorly controlled hypertension.
10) Poorly controlled diabetes mellitus in spite of continuous use of insulin.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Kitagawa
Organization Keio University School of Medicine
Division name Department of Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email kitagawa@a3.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroya Takeuchi
Organization JCOG1409 Coordinating Office
Division name Department of Surgery, Keio University School of Medicine
Zip code
Address 35 Shinanomachi, Shinju-ku, Tokyo
TEL 03-3353-1211
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 Cente
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 岩手医科大学(岩手県)
栃木県立がんセンター(栃木県)
埼玉県立がんセンター(埼玉県)
国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
国立病院機構東京医療センター(東京都)
慶應義塾大学病院(東京都)
がん研究会有明病院(東京都)
虎の門病院(東京都)
東海大学医学部(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
静岡県立総合病院(静岡県)
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)
大阪大学医学部(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)
神戸大学医学部(兵庫県)
兵庫県立がんセンター(兵庫県)
広島大学病院(広島県)
広島市立安佐市民病院(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)
熊本大学医学部(熊本県)
大分大学医学部附属病院(大分県)

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 20 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
2015 Year 03 Month 19 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 20 Day
Last follow-up date
2027 Year 05 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 20 Day
Last modified on
2015 Year 05 Month 20 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020026

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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