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Trial Title:
Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer
NCT ID:
NCT06310369
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Carcinoma in Situ
Conditions: Keywords:
NMIBC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
radiation therapy
Description:
Radiation therapy will be given in 20 fractions of 2.75 Gy covering the whole bladder
over 4 weeks.
The use of a radiosensitizing agent is mandatory. Each recruiting center will have to
choose 2 options of radiosensitizing agents.
Arm group label:
Radiotherapy arm
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 Ta/T1 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18 years or older with histologically confirmed, BCG-unresponsive, high-risk
non-muscle-invasive bladder cancer of predominantly (>50%) urothelial histology who
were ineligible for or declined to undergo radical cystectomy
- Patients with carcinoma in situ with or without high-grade Ta or T1
- Eastern Cooperative Oncology Group performance status of 0-2, and adequate organ
function
- Patients with concomitant Ta and T1 tumours must have undergone complete TURBT,
defined as per standard of care as a visually complete resection (residual carcinoma
in situ, which is traditionally not amenable to complete transurethral resection is
acceptable), and the most recent cystoscopy or TURBT must have been done within 12
weeks before study initiation. Presence of detrusor muscle on pathology samples is
required to ensure sample adequacy. A second TURBT is recommended but not required
for patients with T1 tumours. The use of either white-light cystoscopy or blue-light
cystoscopy is permitted, but the same technique has to be used in a patient
throughout the trial
- Definition of BCG unresponsive non-muscle-invasive bladder cancer according to the
European Association of Urology (EAU) guidelines
Exclusion Criteria:
- Evidence of upper urinary tract carcinoma
- Hydronephrosis due to tumour in the presence of T1 disease
- Patients on current systemic therapy for bladder cancer
- Patients who have received pelvic external beam radiotherapy within the previous 5
years
Gender:
Male
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Start date:
March 1, 2025
Completion date:
March 1, 2030
Lead sponsor:
Agency:
European Organisation for Research and Treatment of Cancer - EORTC
Agency class:
Other
Source:
European Organisation for Research and Treatment of Cancer - EORTC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06310369