A phase II randomised feasibility study of chemoresection or surgical management in low risk non muscle invasive bladder cancer

• Register: ISRCTN
• Last refreshed on: 29 August 2022
• Main ID: ISRCTN24855462
• Date of registration: 15/01/2015
• Prospective Registration: Yes
• Primary sponsor: The Institute of Cancer Research
• Public title: A phase II randomised feasibility study of chemoresection or surgical management in low risk non muscle invasive bladder cancer
• Scientific title: A phase II randomised feasibility study of chemoresection or surgical management in low risk non muscle invasive bladder cancer
• Date of first enrolment: 28/01/2015
• Target sample size: 174
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN24855462
• Study type: Interventional
• Study design: Randomised; Interventional (Treatment)
• Phase: Phase II

Countries of recruitment

England, United Kingdom

Contacts

• Name: Steven Penegar

Key inclusion & exclusion criteria

Inclusion criteria:
Current inclusion criteria as of 29/03/2017:
1. Written informed consent
2. NMIBC recurrence following original diagnosis of low risk NMIBC (defined as Ta G1 or Ta G2 (Ta low grade) with a risk of recurrence score of =6 using EORTC risk tables).
3. Histologically confirmed TCC at original diagnosis
4. Aged 16 or over
5. Satisfactory pre-treatment haematology values haemoglobin > 100 g/L and serum creatinine < 1.5xULN
6. Negative pregnancy test for women of child-bearing potential

Previous inclusion criteria from 12/10/2016 to 29/03/2017:
1. Written informed consent
2. NMIBC recurrence following original diagnosis of low risk NMIBC (defined as Ta G1 or Ta G2 (Ta low grade) with a risk of recurrence score of =5 using EORTC risk tables).
3. Histologically confirmed TCC at original diagnosis
4. Aged 16 or over
5. Satisfactory pre-treatment haematology values haemoglobin > 100 g/L and serum creatinine < 1.5xULN
6. Negative pregnancy test for women of child-bearing potential

Original inclusion criteria:
1. Written informed consent
2. NMIBC recurrence following original diagnosis of low risk NMIBC (defined as Ta G1 or Ta G2 NMIBC with a risk of recurrence score of <=5 using EORTC risk tables)
3. Histologically confirmed TCC at original and any subsequent diagnoses
4. Aged 16 or over
5. Satisfactory pre-treatment haematology values Hb > 100 g/L and serum creatinine < 1.5xULN
6. Negative pregnancy test for women of child-bearing potential

Exclusion criteria:
Current exclusion criteria as of 29/03/2017:
1. Any history of: grade 3/high grade or =T1 transitional cell carcinoma, concomitant carcinoma in situ, more than 7 tumours at one diagnosis or more than 1 recurrence per year since initial diagnosis or in the past five years, whichever is shorter
2. Any history of histologically confirmed non-TCC bladder cancer
3. Trial entry recurrence identified within 11.5 months of the date of the original diagnosis
4. Any prior treatment of the trial entry recurrence (including biopsy)
5. Previous MMC chemotherapy other than a single instillation at diagnostic surgery
6. Known allergy to MMC
7. Carcinoma involving the prostatic urethra or upper urinary tract (participants should have had imaging of the upper urinary tract within 2 years prior to randomisation)
8. Known or suspected reduced bladder capacity (<100ml)
9. Significant bleeding disorder
10. Female patients who are breast-feeding or are of childbearing potential and unwilling or unable to use adequate non-hormonal contraception. Male patients should also use contraception if sexually active.
11. Active or intractable urinary tract infection
12. Urethral stricture or anything impeding the insertion of a catheter
13. Large narrow neck diverticula
14. Significant urinary incontinence
15. Any other conditions that in the Principal Investigator’s opinion would contraindicate protocol treatment
16. Unable or unwilling to comply with study procedures or follow up schedule

Previous exclusion criteria from 12/10/2016 to 29/03/2017:
1. Any history of: grade 3/high grade or T1 transitional cell carcinoma, concomitant carcinoma in situ, more than 7 tumours at one diagnosis or more than 1 recurrence per year since initial diagnosis or in the past five years, whichever is shorter
2. Any history of histologically confirmed non-TCC bladder cancer
3. Trial entry recurrence identified within 11.5 months of the date of the original diagnosis
4. Previous MMC chemotherapy other than a single instillation at diagnostic surgery
5. Known allergy to MMC
6. Carcinoma involving the prostatic urethra or upper urinary tract (participants should have had imaging of the upper urinary tract within 2 years prior to randomisation)
7. Known or suspected reduced bladder capacity (<100ml)
8. Significant bleeding disorder
9. Female patients who are breast-feeding or are of childbearing potential and unwilling or unable to use adequate non-hormonal contraception. Male patients should also use contraception if sexually active
10. Active or intractable urinary tract infection
11. Urethral stricture or anything impeding the insertion of a catheter
12. Large narrow neck diverticula
13. Significant urinary incontinence
14. Any other conditions that in the Principal Investigator’s opinion would contraindicate protocol treatment
15. Unable or unwilling to comply with study procedures or follow up schedule

Original exclusion criteria:


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Topic: Cancer; Subtopic: Bladder Cancer; Disease: Bladder (superficial)
Cancer

Intervention(s)

Chemoresection group: 4 once weekly instillations of 40mg MMC as outpatients
Surgical management group: Surgery according to local practice

Primary Outcome(s)

Complete response to chemoresection 3 months post-treatment

Secondary Outcome(s)

Added 12/10/2016:

In the chemoresection group:
1. Treatment compliance

In both groups:
2. Time to recurrence in patients disease free at 3 months
3. Transurethral resection and biopsy rates
4. Progression-free survival
5. Toxicity
6. Quality of life
7. Health service utilisation

Secondary ID(s)

NCT02070120

17640

2013-005095-18

Source(s) of Monetary Support

National Institute for Health Research

Ethics review

Status:
Approval date:
Contact:

NRES Committee South Central - Hampshire B, 29/08/2014, ref: 14/SC/1223

Results

• Results available: Yes
• Date Completed: 30/09/2019