Combined Postoperative Radiotherapy With Kidney Sparing Surgery for Locally Advanced High-risk Ureteral Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXuesong Li

About this trial

In this study, we propose to conduct an ambispective study to analyze the safety of preserved renal unit surgery combined with postoperative adjuvant radiotherapy in patients with limited stage ureteral cancer with high risk factors, and the efficacy analysis compared with traditional radical surgery. It is hoped that a treatment method that preserves patients' renal function to improve the tolerance of subsequent drug therapy without decreasing the effect of tumor treatment can be achieved in patients with high-risk factors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

1) Distant metastasis or retroperitoneal lymph node metastasis (N+) had been detected at the time of surgery; R2 resection patients; history of bladder cancer; 2) History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; 3) Pregnant women or breastfeeding women; or women of childbearing potential who are not practicing reliable contraception; (4) The presence of active infections in those with pre-existing or coexisting bleeding disorders 5) clinically significant cardiac disease (e.g., hypertension controlled with medications, unstable angina, New York Heart Association (NYHA) class ≥II congestive heart failure, unstable symptomatic arrhythmias, or class ≥II peripheral vascular disease); 6) Psychological, family, and social factors leading to lack of informed consent.

Trial population

Ureteral cancer patients with high-risk factors (high-risk factors define multifocal; G3; T2-4)

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Radical surgery

    Procedure/Surgery

    Radical nephroureterectomy

  • Kidney sparing surgery+Postoperative radiotheray

    Radiation

    Kidney sparing surgery+Postoperative radiotheray

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Kidney sparing surgery+Postoperative radiotheray cohort1 intervention
Group B: Radical surgery cohort1 intervention

Trial outcomes

Primary outcomes

1

Local recurrence free survival (LRFS)

Local recurrence

Time frame
1-year, 3-year and 5-year
2

Renal Function Indicators

eGFR, Crea

Time frame
Perioperation and peri-treatment

Secondary outcomes

1

Metastasis free survival (MFS)

Distant metastasis

Time frame
1-year, 3-year and 5-year
2

Overall survival (OS)

Overall survival

Time frame
1-year, 3-year and 5-year
3

Intravesical and contralateral recurrence free survival(IRFS and CRFS)

Intravesical and contralateral recurrence free survival

Time frame
1-year, 3-year and 5-year
4

Adverse effects (AE)

Adverse effects

Time frame
Perioperation and peri-treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuesong Li

Lead sponsor

Peking University First Hospital

Sponsor institution