Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652022
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Radiotherapy Combined with Systemic Therapy Versus Systemic Therapy for Oligometastatic UTUCs
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Radiotherapy Combined with Systemic Therapy Versus Systemic Therapy for Oligometastatic Upper Tract Urothelial Carcinoma a Prospective Randomised Controlled Trial
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 was a prospective open-label phase II randomised controlled clinical study enrolling patients with primary oligometastatic uroepithelial carcinoma oligometastasis was defined as 3 organs and the number of metastatic lesions and size of metastases were not restricted to be able to satisfy the definition of full-coverage radiotherapy with the exception of patients with brain metastases and more than 3 liver metastases
If regional lymph node recurrence was present all positive regional lymph nodes were collectively referred to as one lesion Non-regional lymph node metastases were counted as the number of metastases by lymph node subregion
Patients were divided into two groups according to whether they received radiotherapy or not 1 systemic therapy group 2 systemic therapy radiotherapy group Systemic drug therapy can be chosen from chemotherapy or immune checkpoint inhibitor therapy or combination therapy
If regional lymph node recurrence was present all positive regional lymph nodes were collectively referred to as one lesion Non-regional lymph node metastases were counted as the number of metastases by lymph node subregion
Patients were divided into two groups according to whether they received radiotherapy or not 1 systemic therapy group 2 systemic therapy radiotherapy group Systemic drug therapy can be chosen from chemotherapy or immune checkpoint inhibitor therapy or combination therapy
Detailed Description:
This study was a prospective open-label phase II randomised controlled clinical study enrolling patients with primary oligometastatic uroepithelial carcinoma oligometastasis was defined as 3 organs and the number of metastatic lesions and size of metastases were not restricted to be able to satisfy the definition of full-coverage radiotherapy with the exception of patients with brain metastases and more than 3 liver metastases
If regional lymph node recurrence was present all positive regional lymph nodes were collectively referred to as one lesion Non-regional lymph node metastases were counted as the number of metastases by lymph node subregion
Patients were divided into two groups according to whether they received radiotherapy or not 1 systemic therapy group 2 systemic therapy radiotherapy group Systemic drug therapy can be chosen from chemotherapy or immune checkpoint inhibitor therapy or combination therapy
If regional lymph node recurrence was present all positive regional lymph nodes were collectively referred to as one lesion Non-regional lymph node metastases were counted as the number of metastases by lymph node subregion
Patients were divided into two groups according to whether they received radiotherapy or not 1 systemic therapy group 2 systemic therapy radiotherapy group Systemic drug therapy can be chosen from chemotherapy or immune checkpoint inhibitor therapy or combination therapy
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