Investigating Bladder Chemotherapy Instead of Surgery for Low Risk Bladder Cancer (CALIBER)

Phase 1

• Conditions: ow risk non muscle invasive bladder cancer; MedDRA version: 20.0 Level: PT Classification code 10005005 Term: Bladder cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-005095-18-GB
• Lead Sponsor: The Institute of Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-12
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 89

Inclusion Criteria

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

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 74

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified