A Phase II, Open Label, Multicenter Randomised Controlled Trial Comparing Hyperthermia Plus Mitomycin To Mitomycin Alone, In Patients with Intermediate Risk Non-Muscle Invasive Bladder Cancer

Phase 2

Completed

• Conditions: Topic: Cancer; Subtopic: Bladder Cancer; Disease: Bladder (advanced), Bladder (superficial); Cancer; Bladder, unspecified

• Registration Number: ISRCTN23639415
• Lead Sponsor: Queen Mary University of London (UK)

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35999119/ (added 24/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-17
• Study Completion: 2017-10-01
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 259

Inclusion Criteria

1. New or Recurrence of intermediate risk NMIBC following TURBT defined as;
1.1.Grade 2 or grade 1 stage Ta or T1 disease*.
1.2. Any grade G2 or G1 recurrent bladder cancer other than low-risk and muscle-invasive disease
2. Age = 18 years
3. WHO performance status 0, 1, 2, 3
4. Normal kidneys and ureters on imaging study within the past 12 months**
5. Pre-treatment haematology and biochemistry values within acceptable limits:
5.1. Haemoglobin (greater than or equal to)10 g/dl
5.2. Neutrophil count (Greater than or equal to)1.5 x 10^9/l
5.3. Platelets (Greater than or equal to) 100 x 10^9/l
5.4. WBC (Greater than or equal to) 3.0 X 10^9/l or ANC greater than or equal to 1.5 X 10^9/l
5.5. Serum creatinine < 1.5 X UNL
6. Negative pregnancy test for women of childbearing potential.
7. Available for longterm followup.
8. Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
9. Written informed consent.

*T1 disease must have evidence of muscle in specimen. If muscularis propria is not present, a reresection should be performed (accordance with National best practice policy)

**Imaging of upper tracts by CT or US scan is routinely performed in some centres and is recommended as good practice in this study

Target Gender: Male & Female ; Lower Age Limit 18 years

Exclusion Criteria

1. Grade 3 TCC
2. Carcinoma in situ
3. New solitary Ta G1 (Small)<3cm
4. New solitary Ta G2 (Small)<3cm
5. Previous intravesical chemotherapy in the past 6 months, other than single instillation postTUR.
6. History of limited vesicle capacity (<200cc)
7. UCC involving the prostatic urethra or upper urinary tract.
8. Greater than or equal to T2 UCC
9. Known allergy to mitomycin
10. Pregnant or lactating women or women of childbearing potential unwilling or unable to use adequate nonhormonal contraception.
11. Other malignancy within the past five years, except: non-melanomatous skin cancer cured by excision, adequately treated carcinoma in situ of the cervix or DCIS/LCIS of the breast or prostate cancer with less than 5yrs life expectancy.
12. Concurrent chemotherapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Objective; Timepoint(s): To determine if HIVEC increases disease-free survival at 24 months compared to the comparator arm of

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration