A Clinical trial to establish the appropriate line of management of Non Muscle Invasive Bladder Cancers who have had their intravesical BCG therapy interrupted

An open label multi-centre randomized control trial for reinitiating intravesical BCG therapy vs resumption in patients of Non Muscle Invasive Bladder Cancer with interruption of therapy due to the COVID-19 (ICON STUDY) - ICON

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/025798

Enrollment

Registered

2020-06-10

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: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: C679- Malignant neoplasm of bladder, unspecified

Interventions

Intervention1: Intervention Arm 1: Reinitiation of intravesical BCG from the beginning of the regimen 120 mg of intravesical BCG dissolved in 50 ml Normal Saline instilled in bladder via a per urethra

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged more than 18 years 2. Patients having high risk NMIBC (T1 or CIS or HG, {multiple, recurrent, and large TaG1G2 all features must be present} ) and Intermediate risk (TaG1/G2 with multiple, recurrent, large tumour) (according to EAU risk stratification) who were planned for BCG therapy but not started. 3. Patients who have received intravesical BCG therapy and whose treatment was not complete as on 25th March, 2020

Exclusion criteria

Exclusion criteria: 1.Low risk group (Ta LG, 2.History of BCG intolerance 3.Patients who have completed BCG intravesical therapy as on march 25th, 2020.

Design outcomes

Primary

Measure	Time frame
1. To determine the recurrence rates, grade and stage progression in NMIBC patients with restarting the intravesical BCG regimen versus continuing the regimen, stratified by different phases of interruption. Timepoint: At completion of accrual, 1 year, 3 years and 5 years	—

Secondary

Measure	Time frame
1. To determine the Overall Survival, Cancer Specific Survival and Progression Free Survival for the two different treatment strategies in patients of NMIBC interrupting their treatment 2. To determine the impact of COVID-19 pandemic on the rates of recurrence or progression due to interruption of intravesical therapy To determine the rates of infectivity of SARS-CoV-2 virus in patients of NMIBC on BCG therapyTimepoint: At completion of accrual, 1 year, 3 years and 5 years	—

Measure

Time frame

1. To determine the Overall Survival, Cancer Specific Survival and Progression Free Survival for the two different treatment strategies in patients of NMIBC interrupting their treatment 2. To determine the impact of COVID-19 pandemic on the rates of recurrence or progression due to interruption of intravesical therapy To determine the rates of infectivity of SARS-CoV-2 virus in patients of NMIBC on BCG therapyTimepoint: At completion of accrual, 1 year, 3 years and 5 years

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Countries

India

Contacts

Public ContactTushar Aditya Narain

AIIMS, Rishikesh

aditya.tushar@gmail.com8146690201

Outcome results

None listed

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