Skip to content

Assessment of first-line ChemoTherapy In adVanced urothElial carcinoma: a PROspective cohort study (PRO-ACTIVE)

Assessment of first-line ChemoTherapy In adVanced urothElial carcinoma: a PROspective cohort study (PRO-ACTIVE)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0010141
Enrollment
300
Registered
2025-01-17
Start date
2024-06-24
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

None listed

Interventions

None listed

Sponsors

Hanyang University Seoul Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Histologic or cytological diagnosis of urinary epithelial cell carcinoma ? Patients who are scheduled to start standard chemotherapy or are currently maintaining primary or secondary chemotherapy due to locally advanced, metastatic or recurrent diseases that cannot be cured using resection or multi-faceted treatment ? 19 years of age or older ? Platinum eligible (ECOG PS 0-2 and GFR = 30ml/min) ? A patient with a written informed consent with a date and signature stating that the patient (or legal representative) participates in the study after receiving sufficient information about the study

Exclusion criteria

Exclusion criteria: ?Tissue types other than urinary epithelial cell carcinoma (registration is possible if squamous epithelial cell carcinoma or adenocarcinoma is shown in urinary epithelial cell carcinoma) ? Patients who have completed secondary chemotherapy (avelumab maintenance is considered secondary chemotherapy, and if abelumab maintenance is applied and treatment is completed, registration is not possible.) ? Previous systemic chemotherapy (However, topical treatment such as intra-bladder chemotherapy is irrelevant). In addition, pre- or post-operative chemotherapy based on previous cisplatin and recurrence at least one year later can be enrolled in this study if other conventional chemotherapy has not been performed.) ? chemotherapy other than standard treatment (e.g., patients enrolled in clinical trials; however, patients enrolled in clinical trials but assigned to the current standard treatment group can be enrolled) ? Patients starting at less than 50% capacity

Design outcomes

Primary

MeasureTime frame
Overall survival, OS

Secondary

MeasureTime frame
2nd Progression free survival (2nd PFS);Objective response rate;Causes of discontinuation of treatment;adverse events of special interests (AESIs)

Countries

Korea, Republic of

Contacts

Public ContactJiyoon Kim

Hanyang University Seoul Hospital

yooncr11@naver.com+82-2-2290-8114

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026