Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06395701 |
| Other study ID # |
TRIMODAL-VEJIGA |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2014 |
| Est. completion date |
June 2, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Consorci Sanitari de Terrassa |
| Contact |
Nicolas Feltes Benitez, MD |
| Phone |
937003690 |
| Email |
nicofeltes_81[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
