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CompletedNCT06395701Updated Sep 19, 2024

Trimodality Treatment in Bladder Cancer

An observational study in Bladder Cancer, Urinary Bladder Neoplasms and Bladder Disease, sponsored by Consorci Sanitari de Terrassa. Completed at 1 site in Spain. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Consorci Sanitari de Terrassa · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
18 Years to 100 Years
Sex
All
01

Study summary

Bladder cancer is a malignant disease that affects a large number of people worldwide. An increase in the incidence of this type of cancer has been observed in recent decades, leading to a growing interest in understanding its risk factors, clinical evolution, and possible treatment approaches. This retrospective study aims to retrospectively analyze a cohort of patients diagnosed with muscle-invasive bladder cancer, in whom, after presentation at multidisciplinary oncology committees, the goal of curing the oncological disease while preserving the bladder is considered.

Trimodal therapy (TMT) is the most studied bladder preservation strategy, with oncological outcomes superior to those of isolated therapies (or monotherapies) such as transurethral resection of the bladder tumor (TURBT), radiotherapy, or chemotherapy. TMT consists of complete and maximal TURBT of the bladder tumor, followed by definitive radiotherapy combined with a radiosensitizing agent.

Objectives The main objective is to retrospectively analyze the effectiveness and safety of the trimodal approach in our setting. Collecting and analyzing data from patients treated in our service will provide valuable insight into clinical outcomes and treatment tolerability in this context.

Materials and Methods

  • Study Design A retrospective study will be conducted using data from medical records of patients diagnosed with bladder cancer from 2014 to 2022 and treated with radiotherapy in our Radiation Oncology Service. Demographic data, medical history, risk factors, clinical characteristics, treatments received, and clinical outcomes will be collected.
  • Study Population The study population will include all patients with confirmed diagnoses of non-metastatic muscle-invasive bladder cancer.
Read the detailed description
  • Inclusion Criteria Adult patients (over 18 years old) with histologically confirmed diagnosis of bladder cancer.

Criteria for selecting optimal candidates for trimodal therapy-assessment in Uro-Oncology committees.

-Functional and compatible bladder at the start of the study.

Criteria related to the tumor:

  • cT2
  • Unifocal tumor with a maximum diameter \< 7 cm.
  • Single tumor.
  • Absence of extensive associated carcinoma in situ (CIS).
  • Absence of bilateral hydronephrosis.
  • Absence of lymphovascular invasion.
  • Attempt at macroscopically complete TURBT of the bladder (incomplete does not exclude bladder preservation).

Availability of complete medical records, including demographic data, medical history, imaging study results, treatment details, and follow-up.

  • Data Collection Data will be retrospectively collected from patients' electronic medical records. Standardized forms will be used to record relevant data, including demographic information, medical history, imaging study results, treatment details, and follow-up.
  • Statistical Analysis Descriptive analysis of the data will be performed to summarize the characteristics of the study population and clinical outcomes. Appropriate statistical tests will be used to compare patient subgroups and assess the association between variables of interest and clinical outcomes.
  • Ethical Considerations This study will be conducted following the ethical principles established in the Helsinki Declaration. Approval will be obtained from our hospital's Ethics Committee.
  • Study Limitations Potential limitations of this study may include inherent bias in retrospective studies, incomplete data in some medical records, and variability in treatments administered over time.
02

Conditions studied

  • Bladder Cancer
  • Urinary Bladder Neoplasms
  • Bladder Disease
03

In context

Urinary Bladder Neoplasms

1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.

This study's enrollment of 200 is close to the median of 200 across 410 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Consorci Sanitari de Terrassa is the lead sponsor of 41 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients diagnosed with bladder cancer from 2014 to 2022 and treated with radiotherapy in our Radiation Oncology Service. Demographic data, medical history, risk factors, clinical characteristics, treatments received, and clinical outcomes will be collected

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients (over 18 years old) with confirmed diagnosis of bladder cancer.

Criteria for selecting optimal candidates for trimodal therapy-assessment in Uro-Oncology committees.

-Functional and compatible bladder at the start of the study.

Criteria related to the tumor:

  • cT2
  • Unifocal tumor with a maximum diameter \< 7 cm.
  • Single tumor.
  • Absence of extensive associated carcinoma in situ (CIS).
  • Absence of bilateral hydronephrosis.
  • Absence of lymphovascular invasion.
  • Attempt at macroscopically complete TURBT of the bladder (incomplete does not exclude bladder preservation).

Availability of complete medical records, including demographic data, medical history, imaging study results, treatment details, and follow-up.

Exclusion criteria

Exclusion Criteria:

  • Not availability of complete medical records, including demographic data, medical history, imaging study results, treatment details, and follow-up.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (actual)
Patient registry
No

Interventions

  • Radiationradioteraphy and chemotherapy after RTU --trimodality therapy--

    TMT ( trimodality treatment) consists of complete and maximal TURBT of the bladder tumor, followed by definitive radiotherapy combined with a radiosensitizing agent.

06

What researchers measure

Primary outcomes

  1. Local Control

    Local Control assessed by RECIST criteria with TC, MRI or PET-scan

    Time frame: 5-10 years

Secondary outcomes

  1. Overall Survival

    Defined as the time from diagnose to the date of death from any cause.

    Time frame: Overall Survival [ Time Frame: Participants should be followed continuously during 5-10 years Defined as the time from diagnose to the date of death from any cause.

07

Study locations

1 site
  • Hospital de Terrassa
    Terrassa, Barcelona 08225, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06395701
Lead sponsor
Consorci Sanitari de Terrassa
Responsible party
Nicolas Feltes (M.D, Consorci Sanitari de Terrassa) — Principal investigator
First posted
May 2, 2024
Start date
Apr 1, 2014
Primary completion
Jun 2, 2024
Completion
Jun 2, 2024
Last update
Sep 19, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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