FindTrial
Sign In

Cancer related outcome after instillation of BCG Vs Gemcitabine & Docetaxel(Anticancer drugs) sequentially in superficial bladder cancer.

The short term oncological outcome of intravesical BCG Vs intravesical Gemcitabine/Docetaxel sequential therapy in NMIBC: A Prospective Randomised Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027427
Enrollment
80
Registered
2020-08-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C679- Malignant neoplasm of bladder, unspecified

Interventions

Intervention1: BCG (Danish 1331 strain ) : 120 mg in 50 ml NS,Intravesical,6 induction doses. Maintenance dose:monthly single dose for 1 year in Intermediate risk & for 3 years in high risk group. In

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Intermediate & High risk Non Muscle Invasive Bladder Cancer

Exclusion criteria

Exclusion criteria: Muscle invasive carcinoma urinary bladder Variant Histology Incomplete TURBT Pregnant & lactating women Hepatic & Renal dysfunction Uncontrolled UTI Immunodeficient patient Denial of consent

Design outcomes

Primary

MeasureTime frame
Recurrence free rates of Intravesical BCG & Sequential Gemcitabine & Docetaxel in NMIBCTimepoint: 3 month—

Secondary

MeasureTime frame
Side effect profile in both the groups. Intravesical therapy related urinary symptoms measured by ICIQ-OAB & EORTC QOL-30 questionnaires among both groups.Timepoint: ICIQ-OAB questionnaires at baseline,after weekly Intravesical chemotherapy & at 3 month. EORTC QoL questionnaire at baseline & at 3 month—

Countries

India

Contacts

Public ContactDr Girdhar Singh Bora

PGIMER Chandigarh

girdhar2k@gmail.com8872237755

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026