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NCT Number: NCT06120387

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Departmeng of Urology, Peking University First Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1) Ureteral cancer patients with high-risk factors (high-risk factors define multifocal; G3; T2-4); surgery may be performed with patients undergoing partial terminal ureteral resection or radical nephroureterectomy 2)Age ≥18 years; 3)Completion of abdominopelvic CT 4 weeks before enrollment to exclude distant metastasis and regional lymph node metastasis.
  • Patients did not have other malignant neoplastic diseases in the last 5 years except for non-melanoma of the skin and ductal carcinoma in situ of the breast; Willing to participate in perfecting the necessary examinations and follow-up for the sake of the study, and willing to provide written informed consent.

Exclusion criteria

  • 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.

Treatment and study plan

Radical surgery

Procedure

Radical nephroureterectomy

Kidney sparing surgery+Postoperative radiotheray

Radiation

Kidney sparing surgery+Postoperative radiotheray

Primary outcomes

  1. Local recurrence free survival (LRFS)

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

    Local recurrence

  2. Renal Function Indicators

    Time frame: Perioperation and peri-treatment

    eGFR, Crea

Secondary outcomes

  1. Metastasis free survival (MFS)

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

    Distant metastasis

  2. Overall survival (OS)

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

    Overall survival

  3. Intravesical and contralateral recurrence free survival(IRFS and CRFS)

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

    Intravesical and contralateral recurrence free survival

  4. Adverse effects (AE)

    Time frame: Perioperation and peri-treatment

    Adverse effects

Sponsors and collaborators

Lead sponsor

Xuesong Li

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2028
First posted
Nov 7, 2023
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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