UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054377 |
|---|---|
| Receipt number | R000061966 |
| Scientific Title | A prospective feasibility study of chemotherapy under covered HANAROSTENT placement in stage IV obstructive colon cancer |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/07/09 19:06:22 |
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Basic information
Public title
A prospective feasibility study of chemotherapy under covered HANAROSTENT placement in stage IV obstructive colon cancer
Acronym
A prospective study of chemotherapy with covered SEMS
Scientific Title
A prospective feasibility study of chemotherapy under covered HANAROSTENT placement in stage IV obstructive colon cancer
Scientific Title:Acronym
HANACO study
Region
| Japan |
Condition
Condition
Stage IV obstructive colon cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate feasibility of chemotherapy under SEMS placement for stage IV obstructive colon cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
One-year SEMS-related adverse events
Key secondary outcomes
Progression-free survival of first-line chemotherapy, Overall response rate of first-line chemotherapy, Adverse events of first-line chemotherapy, Overall survival, Surgery-free survival, Overall SEMS-related adverse events, Duration of SEMS patency, Analysis of tumor markers
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age from 20 to 85 years old
2. Pathologically diagnosed colon adenocarcinoma
3. Obstructive colon cancer with successful decompression by placement of HANALOSTENT Naturfit Colon Cover
4. Colon cancer located from ascending to rectosigmoid colon
5. Surgeon has confirmed that the primary tumor is resectable
6. No primary tumor resection and colostomy
7. Explanation of colon resection and colostomy as the standard therapy
8. Oral intake is possible by successful decompression with SEMS placement
9. Confirmation of SEMS patency and no SEMS-related adverse events using CT scan after post-SEMS day 7
10. No history of chemotherapy for colorectal cancer (In recurrence cases, more than 6 months after final administration of adjuvant chemotherapy)
11. No history of radiation for the primary tumor
12. Standard chemotherapy (doublet or treplet cytotoxic agents, and immune checkpoint inhibitors) is possible
13. Life expectancy longer than 3 months
14. ECOG Performance Status 0-2
15. Patients who meet the following criteria on examination within 7 days prior to enrollment
(1) 3,000/mm3 =< WBC < 12,000/mm3
(2) Neutrophil => 1,500/mm3
(3) Platelet => 100,000/mm3
(4) Hemoglobin => 9.0 g/mm3
(5) Total bilirubin =< 2.0 mg/dL
(6) AST =< 100 U/L (Cases with liver metastasis =< 200 U/L)
(7) ALT =< 100 U/L (Cases with liver metastasis =< 200 U/L)
(8) Serum creatinine =< 1.5mg/dL
16. Agreement with signed informed consent
Key exclusion criteria
1. clinical stage T4b
2. Multiple SEMS placement
3. The presence of multiple malignancies
4. BT => 38.0 (celsius)
5. Infections disease that requires systemic treatment
6. The presence of massive body fluids (pleural, ascites, pericardial fluid, etc.)
7. Administration of anticoagulant drugs or multiple antiplatet drugs
8. Impossible cases that conduct surgery under general anesthesia
9. Sever heart and lung dysfunction
10. Administration of steroid or immune suppressive drugs
11. Uncontrolled diabetes mellitus
12. Active bleeding
13. History of serious drug hypersensitivity
14. Women who are pregnant, possibly pregnant, within 28 days postpartum, or lactating, or who are unwilling to use contraception. Men who do not intend to use contraception.
15. Severe mental disorder
16. Impossible confirmation of own will (ex. dementia)
17. Inappropriateness with physician's judgement
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Takaya |
| Middle name | |
| Last name | Shimura |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
052-853-8211
tshimura@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Sugimura |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
052-853-8211
Homepage URL
naomisug@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
M.I. Tech Co., Ltd.
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
South Koria
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Management Center, Nagoya City University Hospital
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
Tel
052-851-5511
clinical_research@med.nagoya-cu.ac.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
愛知医科大学病院（愛知県）、日本赤十字社愛知医療センター名古屋第二病院（愛知県）、岐阜県立多治見病院（岐阜県）、豊川市民病院（愛知県）、名古屋市立大学附属西部医療センター（愛知県）、名古屋市立大学附属東部医療センター（愛知県）、名古屋市立大学附属みどり市民病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study period: IRB approvement - 12/31, 2030
Study enrollment: IRB approvement - 12/31, 2026
Follow-up period: Enrollment of the first case - 12/31, 2029
All cases will be followed up for 3 years from the date of case enrollment.
Management information
Registered date
| 2024 | Year | 05 | Month | 12 | Day |
Last modified on
| 2024 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061966
