The study of Preventive Approach for Skin Trouble caused by Enfortumab vedotin treatment for urothelial cancer

Not Applicable

Recruiting

• Conditions: rothelial carcinoma; Urothelial carcinoma, Enfoltumab vedotin, Skin disorder; Carcinoma, Transitional Cell

• Registration Number: JPRN-jRCTs031220257
• Lead Sponsor: itta Satoshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-08
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1) Patients who have agreed to be treated with enfoltumab vedotin for metastatic urothelial carcinoma
2) Patients who are at least 18 years of age at the time of consent
3) Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2
4) Patients who are estimated by the attending physician to be expected to survive at least 3 months
(5) Patients who have been fully informed about the study and who have written consent based on their full understanding of the study.

Exclusion Criteria

1) Patients with hypersensitivity to heparinoid from animal organs
2) Patients already using hydrate foam animal organs
3) Patients who are applying steroid agent to the entire body
4) Patients with Grade 2 or higher skin disorder according to the CTCAE 5th edition at the time of enrollment.
5) Patients with any disease requiring oral or intravenous corticosteroid (prednisone equivalent >10 mg/day) or other immunosuppressive drugs within 14 days prior to enrollment.
6) Other patients deemed inappropriate as subjects by the Principal Investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified