Clinical trial · Interventional
Hyperthermic Intra-Vesical Chemotherapy
A Phase II, Open Label, Multicentre, Randomised Controlled Trial Comparing Hyperthermia Plus Mitomycin To Mitomycin Alone In Patients With Intermediate Risk Non-Muscle Invasive Bladder Cancer
NCT06768346CI-TRIAL-00084532HIVECIIcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperthermia will be delivered in combination with each instillation using the Combat BRS system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Mitomycin
- description
- Patients will receive six consecutive weekly instillations of Mitomycin followed by surveillance
- type
- EXPERIMENTAL
- label
- Hyperthermia+Mitomycin
- description
- Patients will receive 6 weekly instillations of hyperthermia plus Mitomycin (HIVEC) using the COMBAT system, followed by surveillance cystoscopy.
- interventionNames
- Device: Hyperthermia will be delivered in combination with each instillation using the Combat BRS system
Primary outcomes (1)
- measure
- To determine if HIVEC increases disease-free survival at 24 months compared to the comparator arm of MM alone.
- timeFrame
- After the last patient has completed 24 months follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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 2. Age ≥ 18 yrs 3. WHO performance status 0, 1, 2, 3 4. 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 5. Negative pregnancy test for women of child-bearing potential. 6. Available for long-term follow-up. 7. 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. 8. Written informed consent. Exclusion Criteria: 1. Grade 3 TCC 2. Carcinoma in situ. 3. New solitary Ta G1 (small) 4. New solitary Ta G2 (small) 5. Previous intravesical chemotherapy in the past 6 months, other than single instillation post-TUR. 6. Bladder capacity \<200cc. 7. UCC involving the prostatic urethra or upper urinary tract. 8. \> or =T2 UCC 9. Known allergy to mitomycin 10. Pregnant or lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal 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 more than 5yrs life expectancy or any non lifethreatening tumours that have been curatively treated. 12. Concurrent chemotherapy.
References
Publications (0)
Data not yet available
No reference posted for this study.