NCT06395701Completed
Trimodality Treatment in Bladder Cancer
Retrospective Study Protocol on Bladder Cancer With Bladder Preservation Intent
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 29 Apr 2024
- Start date
- 1 Apr 2014
- Primary completion date
- 2 Jun 2024
- Lead sponsor
- Consorci Sanitari de Terrassa
- Diseases
- Bladder cancer
- NCT number
- NCT06395701
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 1 Apr 2014 to the primary completion date, 2 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Not availability of complete medical records, including demographic data, medical history, imaging study results, treatment details, and follow-up.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Terrassa Coordinator of this site? Confirm its status | Terrassa | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.