Neoadjuvant Radiotherapy for High-risk UTUC

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Jun 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with high-risk urothelial carcinoma, a type of cancer affecting the kidneys and ureters. The study will explore the effects of neoadjuvant radiotherapy, which means giving radiation treatment before surgery, combined with a major surgery called radical nephroureterectomy (removal of the kidney and ureter). The goal is to see how this treatment helps improve safety and outcomes for patients during and after their treatment.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with high-risk urothelial carcinoma without any distant spread of the disease. They should also have a clear diagnosis from a biopsy and be willing to follow the treatment and follow-up plan provided by their doctors. Participants can expect regular check-ups throughout the treatment process to monitor their health and progress. It's important to note that this trial is not yet recruiting patients, so interested individuals will need to wait until it starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ·≥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 Criteria:
• • 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;
• • Pregnant women or breastfeeding women; or women of childbearing potential who are not using reliable contraception;
• • 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);
• • Psychological, familial, and social factors leading to lack of informed consent.