UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000551 |
|---|---|
| Receipt number | R000000668 |
| Scientific Title | Randomized controlled trial of esophagectomy versus chemoradiotherapy in patients with clinical stage I esophageal carcinoma JCOG0502 |
| Date of disclosure of the study information | 2006/12/20 |
| Last modified on | 2022/08/30 17:45:00 |
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Basic information
Public title
Randomized controlled trial of esophagectomy versus chemoradiotherapy in patients with clinical stage I esophageal carcinoma JCOG0502
Acronym
Randomized controlled trial of esophagectomy versus chemoradiotherapy in patients with clinical stage I esophageal carcinoma JCOG0502
Scientific Title
Randomized controlled trial of esophagectomy versus chemoradiotherapy in patients with clinical stage I esophageal carcinoma JCOG0502
Scientific Title:Acronym
Randomized controlled trial of esophagectomy versus chemoradiotherapy in patients with clinical stage I esophageal carcinoma JCOG0502
Region
| Japan |
Condition
Condition
Esophageal Carcinoma
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the non-inferiority of survival benefit of chemoradiation compared to surgery in stage I esophageal carcinoma.
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
Complete Response Rate, Adverse Events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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:Esophagectomy with D2 (or more) lymph node desection
Interventions/Control_2
B:Chemoradiation
5FU 700mg/m2/day civ Day1-4, 29-32
CDDP 70mg/m2/day div Day1, 29
radiation 60Gy/30fr/6w
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
Male and Female
Key inclusion criteria
(1)Histologically proven esophageal cancer (squamous cell carcinoma, adenosquamous cell carcinoma, besaloid carcinoma)
(2)all lesions are localized in thoracic esophagus.
(3)The depth of main lesion is endoscopically diagnosed submucosa.
(4)No lymphnode metastasis and no distant metastasis.
(5)No prior chemotherapy and/or radiotherapy. Only curative endoscopic mucosal resection is allowed.
(6)ages 20 years-75years
(7)PS(ECOG) 0-1
(8)Normal organic function.
(9)oral or written informed consent obtained before randomization
Key exclusion criteria
(1)synchronous or metachronous (within 5 years) malignancy
(2)Pregnant or lactating
(3)psychiatric medication
(3)Systemic administration of steroids
(4)HBsAg positive
(5)Use of insulin injection therapy or uncontrolled diabetes mellitus
(6)History of acute myocardial infarction (within 3 months) or unstable angina
(7)Severe complecations (COPD, pulmonary fibrillation, heart failure etc.)
(8)active bacterial infection
Target sample size
114
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Igaki |
Organization
National Cancer Center Hospital
Division name
Surgical Oncology
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Kato |
Organization
JCOG0502 Coordinating Office
Division name
Gastrointestinal Oncology, National Cancer Center Hospital
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group(JCOG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
北海道大学病院（北海道）
岩手医科大学（岩手県）
東北大学病院（宮城県）
栃木県立がんセンター（栃木県）
国立がん研究センター東病院（千葉県）
千葉県がんセンター（千葉県）
千葉大学医学部（千葉県）
東京歯科大学市川総合病院（千葉県）
国立がん研究センター中央病院（東京都）
東京女子医科大学（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）
東京医科歯科大学（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）
新潟大学医歯学総合病院（新潟県）
富山大学附属病院（富山県）
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）
京都大学医学部附属病院（京都府）
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）
国立病院機構大阪医療センター（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）
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）
高知医療センター（高知県）
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）
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 12 | 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
Completed
Date of protocol fixation
| 2006 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2006 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2006 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is randomized phaseIII trial which have two arms (group A:Surgery + group B:chemoradiation = 114pts). Even if the patients refuse to be enrolled to the randomized part, patients can be enrolled to the non-randomized part (group C: non-randomized Surgery = 156pts, group D: non-randomized chemoradiation = 156pts). We also verify the non-inferiority of survival benefit between group C and D.
Management information
Registered date
| 2006 | Year | 12 | Month | 20 | Day |
Last modified on
| 2022 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000668
