Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652009
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Radical Radiotherapy Versus Radical Surgery for UTUC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Radical Radiotherapy Compared with Surgical Treatment in Patients with Upper Tract Urothelial Carcinoma a Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 50Gy10f if the tumour is close to the intestine the radiotherapy dose can be appropriately reduced 40-50Gy8-10f to ensure intestinal safety 2With regional lymph node metastasis Renal pelvis tumour tumour PGTV 625Gy25f for tumour larger than 3cm P-SBRT radiotherapy is feasible SBRT 18-24Gy3-4f Affected kidney para-abdominal aorta common iliac lymph node drainage area 475Gy25f metastatic lymph nodes 625Gy25f
3 Routinely segmented normal tissue limits are as follows Contralateral kidney V2015 Dmean 15Gy Duodenum Dmax50Gy Jejunumileumcolon V505 Dmax52Gy Spinal cord Damx 40Gy Liver At least 700cc volume should receive a dose 25Gy
SBRT segmentation Normal tissue limits are as follows
Duodenum Dmax32Gy V185cc Jejunumileumcolon Dmax35Gy V1955cc Stomach Dmax32Gy V185cc 4 Short-term efficacy judgement 1 month after radiotherapy to review imaging short-term efficacy based on RECIST11 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
3 Routinely segmented normal tissue limits are as follows Contralateral kidney V2015 Dmean 15Gy Duodenum Dmax50Gy Jejunumileumcolon V505 Dmax52Gy Spinal cord Damx 40Gy Liver At least 700cc volume should receive a dose 25Gy
SBRT segmentation Normal tissue limits are as follows
Duodenum Dmax32Gy V185cc Jejunumileumcolon Dmax35Gy V1955cc Stomach Dmax32Gy V185cc 4 Short-term efficacy judgement 1 month after radiotherapy to review imaging short-term efficacy based on RECIST11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None