NCT03061630

A Prospective Study of Neoadjuvant Chemotherapy With Gemcitabine/Platinum in Muscle-Invasive or Locally-Advanced Urothelial Carcinoma of Bladder

SAMSUNG MEDICAL CENTER

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Previously-untreated, high-risk (\>T3 and/or N+) muscle-invasive bladder cancer (MIBC) cisplatin 60 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on days 1, 8 and 15. On day 1

Detailed description

Screening numbers are endowed to all patients who sign the informed consent forms. These screening numbers are used as 'Subject Identification Code" along with patient initials. Patients withdrawn from the study retain their screening number. New patients must always be allotted with a new screening number. The study population includes chemotherapy-naïve adults with high-risk MIBC. Patients who meet all of the inclusion criteria and none of the exclusion criteria will receive cisplatin 60 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on days 1, 8 and 15. On day 1, adequate hydration and antiemetics are needed. Study chemotherapy will repeat every 4 weeks on an outpatient basis and continued until disease progression, unacceptable toxicity, deterioration of clinical condition, patient refusal, or up to 2 or 3 cycles, depending on the operation schedules. Patients will be seen every 4 weeks. All study subjects will be also eligible to receive best supportive care (BSC) defined as any standard supportive measures that are not considered a primary treatment of the disease under study, including the use of growth factors (i.e. G-CSF) for myelosuppression, bisphosphonates for management of skeletal metastases, analgesics and transfusion of blood products. BSC will be provided at the discretion of the investigators.

Conditions

• Urinary Bladder

Interventions

Type	Name	Description
DRUG	Gemcitabine	D1.8.15 : GEMCITABINE 1000MG/M2
DRUG	Cisplatin	D1: CISPLATIN 60G/M2

Timeline

• Start date: 2017-02-15
• Primary completion: 2022-03-01
• Completion: 2022-06-01
• First posted: 2017-02-23
• Last updated: 2022-03-08

Locations

2 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study