UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled phase II/III study comparing EBD combined with steroid to RIC combined with steroid for refractory anastomotic stricture after esophagectomy (JCOG1207: RICS study)
Title of the study (Brief title)	A randomized controlled phase II/III study comparing EBD combined with steroid versus RIC combined with steroid for refractory anastomotic stricture after esophagectomy (JCOG1207: RICS study)
Region	Japan

Condition
Condition	Refractory anastomotic stricture after surgical resection for esophageal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the superiority of RIC (Radial Incision and Cutting) with steroid injection in both restenosis-free survival and the number of dilation compared to EBD (Endoscopic Balloon Dilation) with steroid injection in patients with refractory anastomotic stricture after esophagectomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II,III

Assessment
Primary outcomes	Phase II: Proportion of Grade 3/4 intraoperative hemorrhage, esophageal perforation or hemorrhage, pneumothorax, lung or mediastinum infection, or other unexpected adverse reactions. Phase III: Restenosis-free survival; Number of dilation for 24 weeks after treatment
Key secondary outcomes	Phase II/III: Proportion of patients with anastomotic diameter > 10 mm at the time of 8 weeks after treatment; Proportion of adverse events; Proportion of patients experiencing improvement of dysphagia score at the time of 2, 4, 8, 24 weeks after treatment; Proportion of patients with dysphagia score <= 1 at the time of 24 weeks after treatment.

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: EBD (endoscopic balloon dilation) followed by steroid (triamcinolone) injection to the dilated anastomotic stricture. Total amount of injected triamcinolone is 40mg/4ml.
Interventions/Control_2	B: RIC (Radical Incision and Cutting) followed by steroid (triamcinolone) injection to the dilated anastomotic stricture. Total amount of injected triamcinolone is 40mg/4ml.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1 st inclusion criteria 1) Meet all the following criteria about surgery for esophageal cancer: a) Subtotal esophagectomy for thoracic esophageal cancer performed. b) No finding of recurrence. c) Gastric tube reconstruction. d) No residual tumor. 2) Endoscopic balloon dilation (EBD) or bougienage for anastomotic stricture was performed more than twice for 24 weeks. If dilations were performed twice or more within 6 days , dilation was counted as once. 3) No prior history of endoscopic incision for anastomotic stricture. 4) Dysphagia score >=2. 5) Stricture length <=2cm diagnosed by endoscopy or X-ray fluoroscopy. 6) No postoperative chemotherapy for esophageal cancer within 28 days before registration. 7) No prior history of radiotherapy for recurrence after esophagectomy or preoperative radiotherapy more than 60 Gy. 8) No prior history of chemotherapy for any cancer within 28 days before registration. 9) No plan of chemotherapy within 24 weeks after registration. 10) Age>=20 11) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 12) Sufficient organ function 13) Written informed consent 2 nd inclusion criteria At any point after the last dilatation, the presence of anastomotic stricture was confirmed by endoscopic examination performed within 28 days before second registration. The presence of anastomotic stricture is defined as the situation that endoscope (diameter, 9.6 mm-10.4 mm) does not pass through the anastomotic stricture. Pinhole stricture which a device for dilatation or RIC cannot pass through is ineligible.
Key exclusion criteria	1) Active infection requiring systemic therapy 2) Body temperature >=38 degrees Celsius 3) Pregnancy, possible pregnancy within 28 days after delivery or breastfeeding 4) Psychiatric disease 5) Patients requiring systemic steroid medication 6) Patients requiring continuous anticoagulant or antiplatelet drug 7) Poorly controlled hypertension 8) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
Target sample size	130

Research contact person
Name of lead principal investigator	Manabu Muto, MD, PhD
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Therapeutic Oncology
Address	54 Kawaharacho, Shogoin, Sakyo, Kyoto, 606-8507, Japan.
TEL	075-751-4592(81-75-751-4592)
Email	mmuto@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Ikuo Aoyama, MD
Organization	JCOG1207 Coordinating Office
Division name	department of gastroenterology, Japanese Red Cross Otsu Hospital
Address	1-1-35, Nagara, Otsu, Shiga, 520-8511 Japan
TEL	077-522-4131(81-77-522-4131)
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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） 岩手県立中央病院（岩手県） 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） 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） 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（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） 大阪国際がんセンター（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） 医療法人薫風会佐野病院（兵庫県） 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 05 Month 21 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 03 Month 19 Day
Anticipated trial start date	2014 Year 05 Month 21 Day
Last follow-up date	2021 Year 05 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 05 Month 21 Day
Last modified on	2017 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016166