Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598761
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced UTUC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced Upper Tract Urothelial Carcinoma a Prospective Observational Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-09
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 is a prospective cohort study to analyse the safety and efficacy of postoperative adjuvant radiotherapy combined with immunotherapy versus surgery alone group of UTUC patients with T3-4 stages or lymph nodes metastasisN status
Detailed Description:
This study is a prospective cohort study
1 Observation group patients in the observation group were T3-4N pyeloureteral cancer patients who did not tolerate chemotherapy or refused chemotherapy after radical surgery No treatment will be given after surgery and regular review will be conducted
2 Postoperative immunotherapyradiotherapy group
Adjuvant immunotherapy the immunotherapy drug choice is tirilizumab which has been recommended in metastatic uroepithelial cancer in China Tirelizumab 200mg Q3w the duration of immunotherapy is recommended to be used for at least 1 year
Adjuvant radiotherapy can be given concurrently or sequentially with adjuvant immunotherapy it is recommended that radiotherapy can be started within 4-6 weeks after surgery Rotational intensity-modulated radiotherapy VMAT daily image-guided radiotherapy Daily IGRT technique is used
Irradiation range
Renal pelvis and upper ureter ipsilateral renal fossa para-abdominal aorta including upper ureteral alignment area common iliac lymph node area Middle and lower ureteral carcinoma parabasal abdominal aorta renal hilar vessels and following levels common iliac lymph node area right side needs to include paraventricular lymph node area internal and external iliac lymph node area middle and lower ureteral alignment area entrance of the ureteral bladder
Radiotherapy dose 45-50Gy25f5w 625Gy25f5w regimen was given to suspected metastatic lymph nodes visible on imaging Ensure that normal tissue is within the dose limits
Note The right tumour para-abdominal aortic lymph node drainage area needs to include para vena cava intervening vena cava left para-abdominal aorta Left tumour para-abdominal lymph node drainage area needs to include intervening vena cava left para-abdominal aorta
1 Observation group patients in the observation group were T3-4N pyeloureteral cancer patients who did not tolerate chemotherapy or refused chemotherapy after radical surgery No treatment will be given after surgery and regular review will be conducted
2 Postoperative immunotherapyradiotherapy group
Adjuvant immunotherapy the immunotherapy drug choice is tirilizumab which has been recommended in metastatic uroepithelial cancer in China Tirelizumab 200mg Q3w the duration of immunotherapy is recommended to be used for at least 1 year
Adjuvant radiotherapy can be given concurrently or sequentially with adjuvant immunotherapy it is recommended that radiotherapy can be started within 4-6 weeks after surgery Rotational intensity-modulated radiotherapy VMAT daily image-guided radiotherapy Daily IGRT technique is used
Irradiation range
Renal pelvis and upper ureter ipsilateral renal fossa para-abdominal aorta including upper ureteral alignment area common iliac lymph node area Middle and lower ureteral carcinoma parabasal abdominal aorta renal hilar vessels and following levels common iliac lymph node area right side needs to include paraventricular lymph node area internal and external iliac lymph node area middle and lower ureteral alignment area entrance of the ureteral bladder
Radiotherapy dose 45-50Gy25f5w 625Gy25f5w regimen was given to suspected metastatic lymph nodes visible on imaging Ensure that normal tissue is within the dose limits
Note The right tumour para-abdominal aortic lymph node drainage area needs to include para vena cava intervening vena cava left para-abdominal aorta Left tumour para-abdominal lymph node drainage area needs to include intervening vena cava left para-abdominal aorta
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