NCT06652009

Radical Radiotherapy Versus Radical Surgery for UTUC

Efficacy of Radical Radiotherapy Compared with Surgical Treatment in Patients with Upper Tract Urothelial Carcinoma: a Prospective Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective cohort study, and the proposed plan is to recruit 30 patients with radical radiotherapy for renal pelvic ureteral cancer, according to the actual clinical situation, enrolling the same period of time to choose the operation of the elderly, combined with the risk of anaesthesia or regional lymph node metastasis of the patients, initially tentatively set at 60. The patients were divided into the surgery group and radiotherapy group according to the actual choice of treatment. In the control group, standard nephroureterectomy was used, and in the experimental group, stereotactic body radiation therapy (SBRT) or moderately segmented radical radiotherapy was used.

Detailed description

1\) No lymph node metastasis Choose SBRT radiotherapy as much as possible Tumour PTV 50Gy/10f; if the tumour is close to the intestine, the radiotherapy dose can be appropriately reduced 40-50Gy/8-10f; to ensure intestinal safety 2）With regional lymph node metastasis Renal pelvis tumour: tumour PGTV 62.5Gy/25f; for tumour larger than 3cm P-SBRT radiotherapy is feasible, SBRT 18-24Gy/3-4f; Affected kidney + para-abdominal aorta + common iliac lymph node drainage area 47.5Gy/25f; metastatic lymph nodes 62.5Gy/25f. 3\) Routinely segmented normal tissue limits are as follows: Contralateral kidney V20\<15% Dmean 15Gy Duodenum Dmax\<50Gy Jejunum/ileum/colon V50\<5% Dmax\<52Gy Spinal cord Damx \<40Gy Liver At least 700cc volume should receive a dose \<25Gy SBRT segmentation Normal tissue limits are as follows: Duodenum Dmax\<32Gy; V18\<5cc Jejunum/ileum/colon Dmax\<35Gy; V19.5\<5cc Stomach Dmax\<32Gy; V18\<5cc (4) Short-term efficacy judgement: 1 month after radiotherapy to review imaging, short-term efficacy based on RECIST1.1 criteria, partial remission (PR partial regression) or complete remission (CR complete regression); disease-free survival is defined as the period after treatment to the emergence of recurrence in the radiotherapy field, intra-urethral recurrence (except bladder recurrence) or Regional lymph node metastases at first recurrence.

Conditions

• Renal Pelvis Cancer

Interventions

Type	Name	Description
OTHER	Radical nephroureterectomy	Radical nephroureterectomy
RADIATION	Radical radiotherapy	Radical radiotherapy with stereotactic body radiation therapy (SBRT) or moderately segmented radiotherapy

Timeline

• Start date: 2022-01-01
• Primary completion: 2026-12-31
• Completion: 2029-12-30
• First posted: 2024-10-22
• Last updated: 2024-10-22

Locations

2 sites across 1 country: China