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Taking people in SpainPhase 4

Testing chemotherapy inside the bladder before surgery for early bladder cancer

Tests bladder-filled chemotherapy before surgery in adults with early bladder cancer.

Key facts

Who runs it
Hospital Universitario La Paz
Where
Badalona, Granada, Madrid, and Vitoria, SpainSee the 4 sites
Registry title
CLINICAL TRIAL TO EVALUATE BLADDER INSTILLATION OF NEOADJUVANT CHEMOTHERAPY TO TRANSURETHRAL RESECTION OF THE BLADDER FOR THE PREVENTION OF RECURRENCE OF NON-MUSCLE INVASIVE UROTHELIAL CARCINOMA
Status
Recruiting
Phase
Phase 4
People taking part
312 people, planned
Started
18 May 2018
Expected to end
1 May 2029
Type of study
Interventional
Record updated
23 April 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with non-muscle invasive bladder cancer who need surgery to remove the tumour from the bladder (TURBT). It tests whether a chemotherapy drug placed into the bladder before surgery lowers early recurrence.

Age
18 years or older
Sex
Women and men can join
Disease stage
Non-muscle invasive bladder cancer, stage Ta/T1, grade G1-G3, with no carcinoma in situ (CIS). Tumours smaller than 3 cm (1.2 in). A disease-free period of at least 6 months if there was earlier disease.

Main reasons for not taking part

  • Solid or muscle invasive looking tumours
  • Pregnant patients
  • Allergy to Mitomycin C, Epirubicin, Adriamycin, Cisplatin, Gemcitabine or Docetaxel
  • Severe urethral stricture or inability to place a catheter in the bladder
  • Tumours 3 cm (1.2 in) or larger

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Patients of both sexes aged ≥ 18 years
  • Patients with clinical and/or imaging evidence of CVNMI with indication for TURBT
  • Patients with a history of stage CVNMI: Ta/T1, G1-G3, without concomitant CIS (Carcinoma in situ), provided they have a disease-free period of at least 6 months
  • Karnofsky scale score > 70%
  • Patients who agree to participate in the study by signing the informed consent
  • Patients with tumors <3 cm

Who cannot take part

  • Patients with severe urethral stricture or inability to catheterize the bladder for any other reason prior to TURBT
  • Patients with a history of allergy to Mitomycin C, Epirubicin, Adriamycin, Cisplatin, Gemcitabine, Docetaxel
  • Tumors of solid or muscle invasive appearance on cystoscopy and/or preoperative imaging tests
  • Pregnant patients
  • Patients in whom it is foreseen that follow-up is not going to be possible for any reason
  • Patients who for any reason should not be included in the study according to the evaluation of the research team
  • Patients will be excluded from the clinical trial if, after TURBT, their pathological anatomy report shows a diagnosis other than papillary type IMIBC (CIS only, benign lesions, muscle invasive bladder carcinoma, etc.)
  • Patients with tumors ≥ 3 cm will not be included

Where in Spain

  • Hospital Germans Trias i PujolBadalona, SpainTaking people
  • Hospital Universitario Clínico San CecilioGranada, SpainTaking people
  • Hospital Universitario La PazMadrid, SpainTaking people
  • Hospital Universitario ArabaVitoria, SpainTaking people

About the trial

What the trial wants to find out

Evaluation of the rate of early recurrences of CVNMI comparing intravesical instillation of neoadjuvant chemotherapy to TURBT with conventional TURBT without neoadjuvant chemotherapy.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
RANDOMIZED CLINICAL TRIAL, OPEN, TO EVALUATE THE BLADDER INSTILLATION OF NEOADYUVANT CHEMOTHERAPY TO THE TRANSURETHAL RESECTION OF BLADDER FOR THE PREVENTION OF RECURRENCE OF NONMUSCLE-INVASIVE UROTHELIAL CARCINOMA
Plain-language title
Testing chemotherapy inside the bladder before surgery for early bladder cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
23 April 2024