UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057452 |
|---|---|
| Receipt number | R000065648 |
| Scientific Title | A multicenter prospective study to evaluate the safety and changes in quality of life in patients with esophagus squamous cell carcinoma following low radial force stent for residual malignant irreducible stenosis after chemoradiation therapy |
| Date of disclosure of the study information | 2025/10/30 |
| Last modified on | 2025/03/31 02:36:06 |
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Basic information
Public title
A multicenter prospective study to evaluate the safety and changes in quality of life in patients with esophagus squamous cell carcinoma following low radial force stent for residual malignant irreducible stenosis after chemoradiation therapy
Acronym
A multicenter prospective study of low radial force stents in stenting after (chemo-)radiotherapy for squamous cell carcinoma of the esophagus
Scientific Title
A multicenter prospective study to evaluate the safety and changes in quality of life in patients with esophagus squamous cell carcinoma following low radial force stent for residual malignant irreducible stenosis after chemoradiation therapy
Scientific Title:Acronym
A multicenter prospective study of low radial force stents in stenting after (chemo-)radiotherapy for squamous cell carcinoma of the esophagus
Region
| Japan |
Condition
Condition
Squamous cell carcinoma of the esophagus with residual cancerous stricture after CRT/RT, unresectable, and dysphagia score (DS) of >2, difficult oral intake and consideration for stenting
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety and changes in quality-of-life in low radial force stent placement for residual cancerous stenosis after chemoradiation therapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of serious adverse events due to stenting
Key secondary outcomes
Rate of non-worsening of the utility index 1 week after stenting
Rate of improvement in EORTC QLQ-OES18 after 1 week of stenting
Duration of oral intake and rate of duration of oral intake with stenting
Change in Dysphagia Score and rate of improvement with stenting
Rate of success of stenting procedure
Rate of serious adverse events due to percutaneous endoscopic gastrostomy /CV port placement
Rate of improvement in EORTC QLQ-OES18 at 1 and 3 months after stenting and percutaneous endoscopic gastrostomy /CV port placement
Overall survival by each treatment
EQ-5D-5L change by each treatment
Rate of serious adverse events by pretreatment (by radiation dose) and posttreatment history
Rate of Adverse Events by each treatment
Change in Alb, PNI (prognostic nutritional index) after 1 month of treatment by each treatment
Weight change by each treatment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Residual cancerous stenosis after CRT/RT, unable to be radically resected, DS of 2 or more, and difficulty in eating an adequate diet orally, esophageal squamous cell carcinoma to be considered for stenting. Basically, stenting is performed in most cases where the normal diameter does not pass through, but it does not matter whether the normal diameter scope passes through or not.
2) Stenting is performed, or a percutaneous endoscopic gastrostomy or CV port is created or continued.
3) Age 18 years or older at the time of consent.
4) ECOG Performance Status (PS) of 0, 1, or 2.
5) Patients have been fully informed about their participation in the study and their written consent has been obtained.
Key exclusion criteria
1) Patients on peripheral infusion without stenting, percutaneous endoscopic gastrostomy, or CV port
2) Patients with a total radiotherapy dose of less than 30 Gy
3) Patients whose pathology is other than squamous cell carcinoma such as adenocarcinoma
4) Patients with fistulas such as esophagobronchial or esophagopulmonary fistulas
5) Patients with stents other than low radial force stents (Niti-S esophageal stent, Evolution esophageal stent)
6) Patients whose esophageal stricture is close to the pharynx or who have coagulation abnormalities that preclude stenting
7) Patients with infections requiring systemic treatment
8) Pregnant or possibly pregnant or breastfeeding women
9) Patients with psychosis, psychiatric symptoms, or dementia that would make it difficult for them to participate in the study
10) Other patients who are considered by the investigator to be inappropriate to participate in the study
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Yoshio |
Organization
Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Division name
Department of Gastroenterology
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo
TEL
03-3520-0111
toshiyuki.yoshio@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Nobuhito |
| Middle name | |
| Last name | Ito |
Organization
Aichi Cancer Center Hospital
Division name
Department of Endoscopy
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya-shi, Aichi
TEL
052-762-6111
Homepage URL
no.ito@aichi-cc.jp
Sponsor or person
Institute
Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Cancer Institute Foundation Cancer Institute Ariake Hospital
Address
3-8-31 Ariake, Koto-ku, Tokyo
Tel
03-3520-0111
med.shinsa@jfcr.or.jp
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It is an observational study after esophageal stenting or percutaneous Endoscopic Gastrostomy/ CV port.
Management information
Registered date
| 2025 | Year | 03 | Month | 31 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065648
