A prospective feasibility study of chemotherapy under covered HANAROSTENT placement in stage IV obstructive colon cancer

A prospective feasibility study of chemotherapy under covered HANAROSTENT placement in stage IV obstructive colon cancer - HANACO study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000054377

Enrollment

Registered

2024-06-01

Start date

2024-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IV obstructive colon cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
One-year SEMS-related adverse events	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactNaomi Sugimura

Nagoya City University Graduate School of Medical Sciences Department of Gastroenterology and Metabolism

naomisug@med.nagoya-cu.ac.jp052-853-8211

Outcome results