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2024-512683-53-00RecruitingPhase 4

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

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Next steps

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
312 (estimated)
First submitted
8 Apr 2024
Start date
18 May 2018
Lead sponsor
Hospital Universitario La Paz
EU CT number
2024-512683-53-00
EudraCT number
2017-004070-34

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 312
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with severe urethral stricture or inability to catheterize the bladder for any other reason prior to TURBT.

Other illness

  • Patients with a history of allergy to Mitomycin C, Epirubicin, Adriamycin, Cisplatin, Gemcitabine, Docetaxel.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (4)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital Germans Trias i PujolBadalonaSpainRecruiting
Hospital Universitario Clínico San CecilioGranadaSpainRecruiting
Hospital Universitario La PazMadridSpainRecruiting
Hospital Universitario ArabaVitoriaSpainRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.