Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06472752
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-07
Brief Title:
Neoadjuvant Radiotherapy for High-risk UTUC
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
Efficacy and Safety of Neoadjuvant Radiotherapy for High-risk Upper Tract Urothelial Carcinoma A Single-arm Open Label Prospective Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUXUS07
Brief Summary:
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 therapyneoadjuvant radiotherapy withwithout 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
Detailed Description:
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 therapyneoadjuvant radiotherapy withwithout drug like chemotherapy immunotherapy or ADC and etc 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
Two cohorts will be enrolled in the project Cohort 1 high-risk UTUC patients without distant metastases may be accompanied by regional lymph node metastases will receive a short course of neoadjuvant stereotactic radiotherapy neoadjuvant SBRT after completing a biopsy with a clear pathological diagnosis and then undergo a radical surgery within 3 months after the completion of the last radiotherapy Cohort 2 high-risk UTUC patients without distant metastases may be accompanied by regional lymph node metastases will receive short course neoadjuvant SBRT after completing a biopsy and making a clear pathological diagnosis distant metastases may be accompanied by regional lymph node metastases of high-risk UTUC patients who received short-course neoadjuvant stereotactic radiotherapy neoadjuvant SBRT naSBRT drug therapy after completing biopsy and clear pathological diagnosis and were treated with radical surgical therapy full-length radical nephroureterectomy cystocele sleeve resection within 3 months from the completion of the last radiotherapy treatment Drug treatment could be chemotherapyimmunotherapyADC treatment etc
Patients in both cohorts were evaluated by physicians after radical surgery for the need of additional adjuvant therapies including but not limited to chemotherapyimmunotherapytargeted or other molecular therapies etc for 3 months after surgery based on pathological diagnosis during which time the patients adverse reactions and quality of life scores were closely monitored and recorded
Postoperatively each enrolled patient received regular review including but not limited to CT MRI ultrasound blood and urine routine cystoscopy every 3 months for 2 years after surgery and every 6 months for 3-5 years after surgery as recommended by current guidelines When target events including death local recurrence including retroperitoneal lymph node metastasis recurrence in the tumour bed in the operation field etc distant metastasis bladder recurrence etc were observed then the time of the first observation and the corresponding type of event were recorded in detail and the time interval from the start of the first neoadjuvant radiotherapy was calculated At the same time blood routine lymphocyte typing information blood and urine specimens pre-operative biopsies and post-radical surgery pathology specimens were collected during the treatment period for the exploratory study of the corresponding molecular markers to evaluate the characteristics of patients organism and the tumour immune microenvironment
Two cohorts will be enrolled in the project Cohort 1 high-risk UTUC patients without distant metastases may be accompanied by regional lymph node metastases will receive a short course of neoadjuvant stereotactic radiotherapy neoadjuvant SBRT after completing a biopsy with a clear pathological diagnosis and then undergo a radical surgery within 3 months after the completion of the last radiotherapy Cohort 2 high-risk UTUC patients without distant metastases may be accompanied by regional lymph node metastases will receive short course neoadjuvant SBRT after completing a biopsy and making a clear pathological diagnosis distant metastases may be accompanied by regional lymph node metastases of high-risk UTUC patients who received short-course neoadjuvant stereotactic radiotherapy neoadjuvant SBRT naSBRT drug therapy after completing biopsy and clear pathological diagnosis and were treated with radical surgical therapy full-length radical nephroureterectomy cystocele sleeve resection within 3 months from the completion of the last radiotherapy treatment Drug treatment could be chemotherapyimmunotherapyADC treatment etc
Patients in both cohorts were evaluated by physicians after radical surgery for the need of additional adjuvant therapies including but not limited to chemotherapyimmunotherapytargeted or other molecular therapies etc for 3 months after surgery based on pathological diagnosis during which time the patients adverse reactions and quality of life scores were closely monitored and recorded
Postoperatively each enrolled patient received regular review including but not limited to CT MRI ultrasound blood and urine routine cystoscopy every 3 months for 2 years after surgery and every 6 months for 3-5 years after surgery as recommended by current guidelines When target events including death local recurrence including retroperitoneal lymph node metastasis recurrence in the tumour bed in the operation field etc distant metastasis bladder recurrence etc were observed then the time of the first observation and the corresponding type of event were recorded in detail and the time interval from the start of the first neoadjuvant radiotherapy was calculated At the same time blood routine lymphocyte typing information blood and urine specimens pre-operative biopsies and post-radical surgery pathology specimens were collected during the treatment period for the exploratory study of the corresponding molecular markers to evaluate the characteristics of patients organism and the tumour immune microenvironment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None