Hyperthermic Intra-Vesical Chemotherapy

NCT06768346 | Completed DMC

• 1 other identifier: BL-2013-04
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of the HIVEC II trial is to find out if the combination of the new technology called hyperthermia (the use of heat) and a drug called mitomycin is more effective than mitomycin alone which is the standard treatment for bladder cancer in reducing the chances of bladder cancer returning.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• To determine if HIVEC increases disease-free survival at 24 months compared to the comparator arm of MM alone.

  The interval in whole days between the date of randomisation into the trial and the earliest of date of detection of recurrent disease, or date (known as Disease- free survival) will be measured. of death from any cause.

  After the last patient has completed 24 months follow-up

Secondary Outcomes (7)

• To determine if HIVEC reduces the risk of recurrence at 3 months compared to the control arm, for patients with intermediate risk disease.

  At the end of study - After all patients have been followed-up for at least 2 years

• Progression Free Survival

  At the end of study - After all patients have been followed-up for at least 2 years

• Recurrence-free survival.

  At the end of study - After all patients have been followed-up for at least 2 years

• To determine if Heated Mytomycin reduces the risk of progression to invasive disease compared to the control arm.

  After all patients have been followed-up for at least 2 years

• To compare overall and disease-specific survival between the Heated Mytomycin and the control arm.

  At the end of study - After all patients have been followed-up for at least 2 years

Study Arms (2)

Mitomycin

NO INTERVENTION

Patients will receive six consecutive weekly instillations of Mitomycin followed by surveillance

Hyperthermia+Mitomycin

EXPERIMENTAL

Patients will receive 6 weekly instillations of hyperthermia plus Mitomycin (HIVEC) using the COMBAT system, followed by surveillance cystoscopy.

Device: Hyperthermia will be delivered in combination with each instillation using the Combat BRS system

Interventions

Hyperthermia will be delivered in combination with each instillation using the Combat BRS system DEVICE

The Combat BRS system is a temperature controlled fluid recirculation system for the delivery of hyperthermic intravesical chemotherapy. The chemotherapy fluid is circulated in a closed system and warmed by an external isolated dry system using a novel innovative laminated aluminium foil heat exchanger with a small priming volume.

Hyperthermia+Mitomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New or Recurrence of intermediate risk NMIBC following TURBT defined as;
• Grade 2 or grade 1 stage Ta or T1 disease\*.
• Any grade G2 or G1 other than Low risk
• Age ≥ 18 yrs
• WHO performance status 0, 1, 2, 3
• Pre-treatment haematology and biochemistry values within acceptable limits:
• Haemoglobin \> or =10 g/dL
• Neutrophil count \> or =1.5 x 109/L
• Platelets \> or = 100 x 109/L
• WBC \> or = 3.0 x 109/L or ANC \> or = 1.5 x 109/L
• Serum creatinine \< 1.5 x UNL
• Negative pregnancy test for women of child-bearing potential.
• Available for long-term follow-up.
• 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.
• Written informed consent.

You may not qualify if:

• Grade 3 TCC
• Carcinoma in situ.
• New solitary Ta G1 (small)
• New solitary Ta G2 (small)
• Previous intravesical chemotherapy in the past 6 months, other than single instillation post-TUR.
• Bladder capacity \<200cc.
• UCC involving the prostatic urethra or upper urinary tract.
• \> or =T2 UCC
• Known allergy to mitomycin
• Pregnant or lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception.
• 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 more than 5yrs life expectancy or any non lifethreatening tumours that have been curatively treated.
• Concurrent chemotherapy.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (14)

Royal United Hospitals Bath NHS Foundation Trust

Bath, United Kingdom

Location

Western General Hospital, Edinburgh

Edinburgh, United Kingdom

Location

Royal Surrey County Hospital NHS Foudation Trust

Guildford, GU2 7XX, United Kingdom

Location

The Clatterbridge Cancer Centre

Liverpool, United Kingdom

Location

Barnet Hospital

London, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust

London, United Kingdom

Location

University College London Hospital, London.

London, United Kingdom

Location

University Hospital of South Manchester

Manchester, M239QZ, United Kingdom

Location

South Tees NHS Trust - James Cook University Hospital

Middlesbrough, United Kingdom

Location

Norfolk & Norwich University Hospitals NHS Foundation Trust

Norwich, United Kingdom

Location

Derriford Hospital

Plymouth, United Kingdom

Location

Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital

Portsmouth, United Kingdom

Location

East Surrey Hospital

Redhill, United Kingdom

Location

New Cross Hospital

Wolverhampton, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Dr John Kelly

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: January 10, 2025
• Study Start: May 8, 2014
• Primary Completion: May 27, 2020
• Study Completion: May 27, 2020
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

GB (14)