Neoadjuvant chemotherapy for locally advanced upper tract urothelial cancer

Neoadjuvant chemotherapy for locally advanced upper tract urothelial cancer - Neoadjuvant chemotherapy for locally advanced upper tract urothelial cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027611

Enrollment

500

Registered

2017-06-02

Start date

2008-06-01

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

Upper tract urothelial carcinoma (UTUC)

Interventions

Neoadjuvant chemotherapy for locally advanced UTUC followed by radical nephroureterectomy. Patients received either gemcitabine 800 mg/m2 on days 1, 8, and 15 plus cisplatin 70 mg/m2 (GCis) on day 2

60 mL/min/1.73m2) or presence of frailty. To reduce delays in surgery, we planned two courses of NAC and surgery within 90 d in accordance with recommendations for muscle-invasive bladder cancer

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Key inclusion criteria: Patients with locally advanced UTUC who is indicated for radical nephroureterectomy. The indications for NAC were locally advanced UTUC, including cT3-4 disease or local lymph node involvement.

Exclusion criteria

Exclusion criteria: Presence of any distant metastases. History of severe cardiac conditions, such as angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study. History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1. Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1. History of drug, alcohol, or substance abuse within the 6 months before Visit 1. Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to neoadjuvant therapy

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Radiologic response, cancer-specific and overall survival, safety, biomarker analysis	—

Countries

Japan

Contacts

Public ContactShingo Hatakeyama

Hirosaki University School of Medicine Urology

shingoh@hirosaki-u.ac.jp0172395091

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026