UMIN-CTR Clinical Trial

Public title

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)

Acronym

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)

Scientific Title

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)

Scientific Title:Acronym

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

Refractory anastomotic stricture after surgical resection for esophageal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Manabu Muto, MD, PhD

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Therapeutic Oncology

Zip code

Address

54 Kawaharacho, Shogoin, Sakyo, Kyoto, 606-8507, Japan.

TEL

075-751-4592(81-75-751-4592)

Email

mmuto@kuhp.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Ikuo Aoyama, MD

Organization

JCOG1207 Coordinating Office

Division name

department of gastroenterology, Japanese Red Cross Otsu Hospital

Zip code

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

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

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

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）

Date of disclosure of the study information

2014

Year

05

Month

21

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

2014

Year

03

Month

19

Day

Date of IRB

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

Other related information

Registered date

2014

Year

05

Month

21

Day

Last modified on

2017

Year

04

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016166