Intravesical Thermochemotherapy With Mitomycin-c

NCT03694535 | Completed

• 1 other identifier: 2014/387
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate effect of intravesical mitomycin-C(MMC) applied with bladder wall thermotherapy system on reccurrence and progression status of intermediate and high risk non muscle invasive bladder cancer

Conditions

Bladder Cancer

Keywords

Thermochemotherapy; bladder; cancer

Outcome Measures

Primary Outcomes (2)

• Recurrence

  recurrence rate of non muscle invasive bladder cancer during or after treatment

  From the beginning of thermochemoterapy until the date of first documented recurrence assessed up to 2 years

• Progression rate

  progression rate of non muscle invasive bladder cancer during or after treatment ( progress to muscle invasive stage or carcinoma in situ)

  From the beginning of thermochemoterapy until the date of first documented progression assessed up to 2 years

Secondary Outcomes (1)

• Side effects

  From the beginning of thermochemoterapy until the date of first documented side effect(s) assessed up to 2 years

Study Arms (1)

Bladder wall thermochemotherapy

EXPERIMENTAL

Mitomycin-C application with bladder wall thermochemotherapy system after TUR bladder tumor in intermediate and high risk non muscle invasive bladder cancer

Drug: bladder wall thermotherapy with Mitomycin-c

Interventions

bladder wall thermotherapy with Mitomycin-c DRUG

application of intravesical mitomycin-C with hyperthermia

Bladder wall thermochemotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• newly diagnosed or followed as recurrent intermediate-risk non muscle invasive non muscle invasive bladder cancer according to the criteria of European Association of Urology.
• newly diagnosed or followed as recurrent high-risk non muscle invasive non muscle invasive bladder cancer according to the criteria of European Association of Urology.
• pathology of urothelial carcinoma

You may not qualify if:

• Low bladder capacity (\<150ml)
• increased post voiding residual urine (\>150ml)
• untreatable or uncontrollable urinary tract infection
• history of urethral stricture
• presence of bladder diverticula larger than 1 cm
• pathology other than urothelial carcinoma
• WHO (World Health Organization) performance status \> 2
• upper urinary tract urothelial carcinoma diagnosis

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Department of Urology, Ercieys University, Faculty Of Medicine,

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (2)

• Moskovitz B, Meyer G, Kravtzov A, Gross M, Kastin A, Biton K, Nativ O. Thermo-chemotherapy for intermediate or high-risk recurrent superficial bladder cancer patients. Ann Oncol. 2005 Apr;16(4):585-9. doi: 10.1093/annonc/mdi124. Epub 2005 Feb 25.

  PMID: 15734775 BACKGROUND

• Colombo R, Salonia A, Leib Z, Pavone-Macaluso M, Engelstein D. Long-term outcomes of a randomized controlled trial comparing thermochemotherapy with mitomycin-C alone as adjuvant treatment for non-muscle-invasive bladder cancer (NMIBC). BJU Int. 2011 Mar;107(6):912-8. doi: 10.1111/j.1464-410X.2010.09654.x. Epub 2010 Oct 4.

  PMID: 21029314 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Neoplasms

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Abdullah Demirtas, MD

  TC Erciyes University Medical Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md, Assoc. Prof.

Model Details: single group of patients composed of intermediate and high risk non muscle invasive bladder cancer

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 3, 2018
• Study Start: January 1, 2012
• Primary Completion: February 28, 2015
• Study Completion: September 15, 2017
• Last Updated: October 3, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)