UMIN-CTR Clinical Trial

Basic information
Public title	A phase III study of oral steroid administration versus local steroid injection therapy for the prevention of esophageal stricture after endoscopic submucosal dissection(JCOG1217, Steroid EESD P3)
Acronym	A phase III study of oral steroid administration versus local steroid injection therapy for the prevention of esophageal stricture after endoscopic submucosal dissection(JCOG1217, Steroid EESD P3)
Scientific Title	A phase III study of oral steroid administration versus local steroid injection therapy for the prevention of esophageal stricture after endoscopic submucosal dissection(JCOG1217, Steroid EESD P3)
Scientific Title:Acronym	A phase III study of oral steroid administration versus local steroid injection therapy for the prevention of esophageal stricture after endoscopic submucosal dissection(JCOG1217, Steroid EESD P3)
Region	Japan

Condition
Condition	Early stage esophageal cancer after endoscopic submucosal dissection (ESD)
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the superiority of oral steroid administration in terms of stricture-free survival over local steroid injection therapy for the patients with early esophageal cancer treated by ESD.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	stricture-free survival
Key secondary outcomes	the number of endoscopic balloon dilation for 12 weeks after ESD, adverse events, serious adverse events, and proportion of patients with dysphagia score =< 1 at the time of 12 weeks after ESD

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: Local steroid (triamcinolone acetonide) injection to the ulcer immediately after ESD. Total amount of injected triamcinolone is 100 mg.
Interventions/Control_2	B: Oral steroid (predonisolone) administration two days after ESD. Predonisolone is administered over 8 weeks, started at 30 mg/day and tapered to 20 mg/day by 5 mg per two weeks, and then to 0 mg by 5 mg per week.
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically proven esophageal squamous cell carcinoma or basaloid cell carcinoma 2) Primary tumor located in the thoracic esophagus confirmed by endoscopy 3) Primary tumor located in the epithelium or lamina propria mucosa or muscularis mucosa confirmed by endoscopy 4) Neither lymph node metastases nor distant metastases in neck, chest and abdomen confirmed by computed tomography 5) Circumferential spread of the major lesion is 1/2 or more, but not entire circumference by endoscopy 6) Length of major lesion is 50 mm or less in longitudinal axis by endoscopy. 7) Circumferential spread 1/2 or less in all sub-lesions in patients with multiple lesions 8) Aged 20 to 85 years old 9) ECOG performance status of 0 to 1 10) No prior radiotherapy to the neck, chest wall, lung, or mediastinum 11) No prior surgery for esophagus or mediastinum 12) No prior treatment for esophageal cancer 13) Dysphagia score of 0 14) Adequate organ functions and HbA1c < 7.0% 15) Written informed consent
Key exclusion criteria	1) Synchronous or metachronous (within 1 years) malignancies 2) Active infection requiring systemic therapy 3) Body temperature >=38 degrees Celsius 4) Pregnancy, possible pregnancy, within 28 days after delivery or breastfeeding 5) Severe psychiatric disease 6) Patients requiring systemic steroid medication 7) Uncontrollable diabetes mellitus 8) Patients requiring continuous anticoagulant or antiplatelet drug 9) Poorly controlled hypertension 10) Histody of unstable angina within 3 weeks or myocardial infarction within 6 months 11) Patients with respiratory disease requiring continuous supplemental oxygen 12) Active gastroduodenal ulcer 13) Glaucoma, posterior capsule opacification or herpetic keratitis 14) History of surgery within 3 months 15) Positive HBs antigen, HBs antibody or HBc antibody 16) Allergy to Iodine 17) Hypersensitivity for triamcinolone acetonide, prednisolone, and proton pump inhibitor 18) Glucose-6-phosphate dehydrogenase deficiency
Target sample size	360

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroyuki Ono
Organization	Shizuoka Cancer Center
Division name	Endoscopy division
Zip code
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777 Japan
TEL	055-989-5222(81-55-989-5222)
Email	h.ono@scchr.jp

Public contact
Name of contact person	1st name Middle name Last name Masaki Tanaka
Organization	JCOG1217Coordinating Office
Division name	Endoscopy division, Shizuoka Cancer Cente
Zip code
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777 Japan
TEL	055-989-5222(81-55-989-5222)
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） 山形県立中央病院（山形県） 福島県立医科大学附属病院（福島県） 茨城県立中央病院・茨城県地域がんセンター（茨城県） 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） 国立がん研究センター中央病院（東京都） 昭和大学病院（東京都） がん研究会有明病院（東京都） 虎の門病院（東京都） NTT東日本関東病院（東京都） 神奈川県立病院機構神奈川県立がんセンター（神奈川県） 横浜市立市民病院（神奈川県） 北里大学医学部（神奈川県） 横浜市立大学附属市民総合医療センター（神奈川県） 新潟大学医歯学総合病院（新潟県） 富山県立中央病院（富山県） 石川県立中央病院（石川県） 佐久総合病院佐久医療センター（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） 愛知県がんセンター愛知病院（愛知県） 京都大学医学部附属病院（京都府） 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） 兵庫医科大学（兵庫県） 兵庫県立がんセンター（兵庫県） 医療法人薫風会佐野病院（兵庫県） 広島大学病院（広島県） 広島市立広島市民病院（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）

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 05 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	No longer recruiting
Date of protocol fixation	2014 Year 07 Month 18 Day
Date of IRB	2014 Year 08 Month 21 Day
Anticipated trial start date	2014 Year 09 Month 05 Day
Last follow-up date	2021 Year 09 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 09 Month 05 Day
Last modified on	2021 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017510