Optimized Treatment Strategy for HighGrade1 (HGT1) Bladder Cancer Based on Substaging: a Prospective Observational Cohort Study

Vall d'Hebron University Hospital (HUVH)

Status: Completed

Conditions: Bladder Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02113501

HighGradeT1 Bladder Cancer HVH

Details and patient eligibility

About

Non-muscle invasive bladder cancer of High Grade stage T1 (HGT1), has up to 20% risk of progression to invasive disease. Because the depth of substaging seems to identify two separate groups with different progression risk (HighGradeT1a and HighGradeT1b), we design a differential treatment strategy for each group. The main hypothesis is that HighGradeT1a bladder cancer can spare a second endoscopic procedure.

Full description

Only cases of initial diagnosis of HighGradeT1 and with a complete transurethral endoscopic resection (TUR) of bladder tumor) can enter this protocol. HighGradeT1a will only receive standard BCG treatment (induction and maintenance). HighGradeT1b will undergo a second transurethral endoscopic resection (TUR) after the induction of Bacillus de Calmette-Guerin (BCG) and then continue mantenaince BCG and standard follow-up.

Enrollment: 200 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• HGT1 bladder cancer at initial diagnosis and after a complete TUR

Exclusion criteria

• abscence of muscularis propria in the TUR specimen

Trial design

200 participants in 2 patient groups

HGT1a

Description:

HGT1a bladder cancer patients will undergo BCG induction and maintenance followed by conventional follow-up (cystoscopy and cytology at 3months and then every 6months).

HGT1b

Description:

HGT1b bladder cancer patients will undergo a 2nd TUR after BCG induction. If negative, continue with maintenance BCG followed by conventional follow-up (cystoscopy and cytology every 6months).