Hyperthermic Intra-Vesical Chemotherapy (HIVECII)

Queen Mary University of London

Status: Completed

Conditions: Bladder Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06768346

BL-2013-04

Details and patient eligibility

About

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.

Full description

The concept of hyperthermia plus MM has been demonstrated and a phase II randomized controlled trial of ablative HM versus MM using an alternative device (Synergo) has reported tumor ablation complete response (CR) rates in 66 % of tumors treated with hyperthermia plus mitomycin compared to 22% CR for MM mono-therapy.

Registered patients will be randomised to receive either Hyperthermia and Mitomycin or Mitomycin alone. Following treatment, patients will be followed up by surveillance cystoscopy for 24 months for disease recurrence. In the first year, the follow up visits will be every 3 months from the date of start of treatment and in the second year, the visits will be every 6 months.

The study also includes translational components to determine biomarkers of response to Heated Mitomycin. Urine samples will be collected prior to surveillance cystoscopies.

This study will address the problem of how to improve the disease free survival in patients with intermediate-risk NMIBC, the treatment must have acceptable side-effects, low toxicity, and show a significant benefit over MM alone.

Enrollment: 259 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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259 participants in 2 patient groups

Mitomycin

No Intervention group

Description:

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

Hyperthermia+Mitomycin

Experimental group

Description:

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

Treatment:

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