Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310369
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-07
Brief Title:
Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ CIS Bladder Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ CIS Bladder Cancer an Open-label Single-arm Multicenter Phase 2 Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
The investigators aim to investigate a possible role for radiotherapy in good prognosis bladder cancer patients has been identified as a possible alternative to cystectomy especially for patients non-eligible for surgery but has yet to be fully explored
Detailed Description:
Bladder cancer is the tenth most commonly diagnosed cancer with urothelial carcinoma representing 90 of all bladder cancer cases Approximately three-quarters of patients diagnosed with urothelial carcinoma have non-muscle invasive disease NMIBC confined to the mucosa stage Ta or carcinoma in situ CIS or submucosa stage T1 The gold standard for diagnosing CIS is a combination of cystoscopy urine cytology and histological evaluation Diagnosis and resection of visible TaT1 tumors is done by transurethral resection of bladder tumors TURBT Standard treatment for patients with high-risk NMIBC high-grade Ta CIS or any T1 following staging consists of intravesical Bacillus Calmette-Guerin BCG immunotherapy BCG even administered optimally does not provide absolute protection BCG failure is generally considered recurrence or progression during therapy Clinical trial data comparing salvage therapies after BCG are quite heterogeneous in part due to inconsistent definitions and reporting methods
Patients who are BCG-unresponsive have a 20-40 risk for progression to muscle-invasive bladder cancer within 5 years which carries a 50 risk for the development of incurable metastatic disease
Interestingly although chemoradiotherapy is a recognized standard of care in muscle-invasive bladder cancer MIBC it has not been adequately explored in NMIBC However the available data suggests that NMIBC is a radioresponsive malignancy and that in a proportion of patients bladder preservation would be possible
The investigators aim to evaluate the use of radiotherapy in patients with high-grade non-muscle-invasive bladder cancer who have BCG failure potentiating its effect with commonly use radiosensitizers
Patients who are BCG-unresponsive have a 20-40 risk for progression to muscle-invasive bladder cancer within 5 years which carries a 50 risk for the development of incurable metastatic disease
Interestingly although chemoradiotherapy is a recognized standard of care in muscle-invasive bladder cancer MIBC it has not been adequately explored in NMIBC However the available data suggests that NMIBC is a radioresponsive malignancy and that in a proportion of patients bladder preservation would be possible
The investigators aim to evaluate the use of radiotherapy in patients with high-grade non-muscle-invasive bladder cancer who have BCG failure potentiating its effect with commonly use radiosensitizers
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