UMIN-CTR Clinical Trial

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

clinical stage I/II/III (excluding T4) thoracic esophageal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES

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

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

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

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

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

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

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

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

National Cancer Cente

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

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）

Date of disclosure of the study information

2015

Year

05

Month

20

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

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 related information

Registered date

2015

Year

05

Month

20

Day

Last modified on

2015

Year

05

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020026