Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy
Conditions
Keywords
kidney-sparing therapy, upper tract urothelial carcinoma
Brief summary
Upper tract urothelial carcinoma (UTUC) is a rare malignant disease which accounts for 5-10% of urothelial carcinoma in the western world and 9%-30% in China. About two thirds of patients have muscle invasive disease at diagnosis. Those patients usually have poor prognosis. The 5 year cancer specific survival is \<50% for pT2/T3 and \<10% for pT4. Radical nephroureterectomy is the standardized treatment for non-metastatic high risk UTUC. However, about half patients may suffer from impaired renal function after nephroureterectomy. On the other hand, kidney sparing surgery can avoid renal function impairment, but the therapy is only recommended for few patients with low-risk disease. The treatment for urothelial carcinoma has changed rapidly in the past few years. Immune checkpoint inhibitors and novel agents such as ADCs have shown promising therapeutic effect and were approved for patients with metastatic UTUC. Meanwhile, a recent study shows that patients with high-risk disease can also receive kidney sparing surgery without compromising cancer specific survival and overall survival. This prospective, observational study aims to evaluate the prognosis of contemporary kidney sparing surgery in patients with UTUC with or without perioperative therapy in the real world.
Detailed description
The patients that meet the Inclusion and Exclusion Criteria will enroll into this observational trial. The therapeutic schedule is purposed to spare the kidney of non-metastatic primary UTUC patients.
Interventions
OTHERObservational
This is a prospective observational study with observation only and no intervention
Sponsors
Shanghai Zhongshan Hospital
Tianjin Medical University Second Hospital
Xiangya Hospital of Central South University
West China Hospital
Ruijin Hospital
First Affiliated Hospital Xi'an Jiaotong University
The First Affiliated Hospital of University of Science and Technology of China
The Second Hospital of Anhui Medical University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
RenJi Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
Minimum Age: 18 Years Maximum Age: 90 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No Criteria: Inclusion Criteria: 1. Histopathological confirmed upper tract urothelial carcinoma; 2. Refused radical nephroureterectomy, or eligible for the indications of kidney-sparing surgery; 3. Participants must be willing to attend the follow-up visits; 4. Sign informed consent.
Exclusion criteria
1. Unable to undergo kidney-sparing surgery; 2. Life expectancy \< 6 months; 3. Previous anti-tumor therapy against UTUC, including systemic chemotherapy, surgery, radiotherapy, or immunotherapy identifying by investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Two-year events-free survival rate | Up to 2 years | events-free survival defined as time from initiation of first protocol therapy until the first time to develop any local recurrence (local/bladder), distant metastases or any cause-related death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Up to 2 years | defined as time from initiation for protocol therapy to death. |
| Metastasis free surviva | Up to 2 years | metastasis free survival defined as time from initiation of protocol therapy until the development of distal metastasis or death |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Up to 2 years | The adverse events are evaluated per Common Terminology Criteria for Adverse Events (CTCAE) 5.0.. |
Countries
China
Contacts
Primary ContactJiwei Huang, Dr
Outcome results
None listed