Radiotherapy Before Surgery for High-risk Upper Urinary Tract Cancer
Studies radiation, with or without drugs, before surgery in adults with upper urinary tract cancer.
Plain-language title generated from the registry record
Registry title: Neoadjuvant Radiotherapy for High-risk UTUC
Key facts
- Where
- Beijing, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with high-risk cancer of the upper urinary tract (renal pelvis or ureter) that has not spread to distant organs. Everyone gets radiotherapy before surgery to remove the kidney and ureter.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- High-risk upper tract urothelial carcinoma, confirmed by biopsy, ureteroscopy or urine cytology, with no distant metastases. High-risk means at least one of: muscle invasion (cT2 and above), high-grade tumour, multifocality, tumour diameter of ≥2cm (0.8 in), hydronephrosis or regional lymph node metastasis.
- Earlier treatment
- People with a history of pelvic or abdominal radiotherapy or systemic chemotherapy cannot join. People must be willing to have radical surgery and treatment around the operation.
Main reasons for not taking part
- Distant metastases or another cancer at the same time
- History of pelvic or abdominal radiotherapy, or of systemic chemotherapy
- History of inflammatory bowel disease
- Pregnant or breastfeeding women, or women who could become pregnant and do not use reliable contraception
- Clinically significant heart disease
Read by machine on 12 November 2026.
Where in China
- Departmeng of Urology, Peking University First HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Peking University First Hospital
- Trial code
- NCT06472752
- Record updated
- 25 June 2024
- Original description
The investigators propose to conduct an open-label, single-arm, prospective cohort study to collect and observe high-risk UTUC patients (with clear pathology of urothelial carcinoma and at least one of the following (muscle invasion [cT2 and above], high-grade tumour, multifocality, tumour diameter of ≥2cm, with hydronephrosis or regional lymph node metastasis) who undergo neoadjuvant therapy(neoadjuvant radiotherapy with/without drug) + radical nephroureterectomy. The cohort was evaluated by regular follow-up for safety and prognosis during the real-world neoadjuvant treatment period, perioperative period, and long-term postoperative follow-up.Read full original descriptionShow less
Efficacy and Safety of Neoadjuvant Radiotherapy for High-risk Upper Tract Urothelial Carcinoma: A Single-arm, Open Label, Prospective Cohort Study
The investigators propose to conduct an open-label, single-arm, prospective cohort study to collect and observe high-risk UTUC patients (with clear pathology of urothelial carcinoma and at least one of the following (muscle invasion [cT2 and above], high-grade tumour, multifocality, tumour diameter of ≥2cm, with hydronephrosis or regional lymph node metastasis) who undergo neoadjuvant therapy(neoadjuvant radiotherapy with/without drug) + radical nephroureterectomy. The cohort was evaluated by regular follow-up for safety and prognosis during the real-world neoadjuvant treatment period, perioperative period, and long-term postoperative follow-up.
Inclusion: ·≥18 years old, no gender limits, diagnosed as high-risk UTUC without existing distant metastasis or other malignancies; Completed pathological biopsy with a clear pathological diagnosis : including puncture biopsy, ureteroscopy and urine cytology, at least one of which is clearly diagnosed as uroepithelial carcinoma, which may include no more than 50% or more proportion of squamous, adenoid, sarcomatoid differentiation and other special differentiation types; Have the willingness to undergo radical surgical treatment and perioperative adjuvant treatment, have good compliance, and be able to co-operate with the treatment and follow-up plan specified by the clinician; Postoperative life expectancy of at least 6 months; ECOG score ≤ 2.
Exclusion: Distant metastases or other malignant neoplastic diseases combined with other malignant neoplasms in the same period had been detected at the time of surgery, or the present was a progression after palliative resection of previous epithelial carcinoma of the urothelium; History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; The presence of active infections in those with pre-existing or coexisting haemorrhagic disorders; 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); Pregnant women or breastfeeding women; or women of childbearing potential who are not using reliable contraception; Psychological, familial, and social factors leading to lack of informed consent.