NCT06472752Not yet recruiting
Neoadjuvant Radiotherapy for High-risk UTUC
Efficacy and Safety of Neoadjuvant Radiotherapy for High-risk Upper Tract Urothelial Carcinoma: A Single-arm, Open Label, Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 25 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 7 Jun 2024
- Start date
- 30 Jun 2024
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Peking University First Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT06472752
What you commit to
- Study type: Observational
- Planned participants: 40
- From 30 Jun 2024 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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);
Other
- 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.
Who the study is looking for
- ·≥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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Departmeng of Urology, Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.