Under construction – not a live service
Sign in
Not yet taking people in ChinaNo phase

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.

Key facts

Who runs it
Peking University First Hospital
Where
Beijing, ChinaSee the site
Trial code
Registry title
Neoadjuvant Radiotherapy for High-risk UTUC
Status
Not yet recruiting
People taking part
40 people, planned
Started
30 Jun 2024
Expected to end
30 Jun 2029
Type of study
Observational, 2 groups
Treatments tested
  • Neoadjuvant radiotherapy
  • Neoadjuvant drug therapy
Record updated
25 June 2024

Who can take part

AI summary

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

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • ·≥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

Who cannot take part

  • 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

Where in China

  • Departmeng of Urology, Peking University First HospitalBeijing, ChinaNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Neoadjuvant radiotherapy+radical surgery

    Patients with high-risk UTUC without distant metastases (which can be accompanied by regional lymph node metastases) were selected to receive short-course neoadjuvant stereotactic radiotherapy (neoadjuvant SBRT, naSBRT) after completion of biopsy and definitive pathological diagnosis, and to undergo radical surgery within 3 months from completion of the last radiotherapy session

    Treatment: Neoadjuvant radiotherapy

  • Neoadjuvant radiotherapy and drug therapy+radical surgery

    Patients with high-risk UTUC without distant metastases (which may be accompanied by regional lymph node metastases) were selected to receive a short course of neoadjuvant stereotactic radiotherapy (neoadjuvant SBRT, naSBRT) + drug therapy after completing a biopsy and making a definitive pathological diagnosis, and to undergo a radical surgical procedure within 3 months from the end of the last radiotherapy session (full-length radical nephroureteral resection + cystocele sleeve resection ) treatment. Pharmacological treatment can be chemotherapy/immunotherapy/ADC treatment etc.

    Treatment: Neoadjuvant radiotherapy and Neoadjuvant drug therapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Efficacy and Safety of Neoadjuvant Radiotherapy for High-risk Upper Tract Urothelial Carcinoma: A Single-arm, Open Label, Prospective Cohort Study
Plain-language title
Radiotherapy Before Surgery for High-risk Upper Urinary Tract CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
25 June 2024