Trimodality Treatment in Bladder Cancer

NCT06395701 | Completed DMC

• 1 other identifier: TRIMODAL-VEJIGA
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer; Urinary Bladder Neoplasms; Bladder Disease

Outcome Measures

Primary Outcomes (1)

• Local Control

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

  5-10 years

Secondary Outcomes (1)

• Overall Survival

  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.

Interventions

radioteraphy and chemotherapy after RTU --trimodality therapy-- RADIATION

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Not availability of complete medical records, including demographic data, medical history, imaging study results, treatment details, and follow-up.

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead

Study Sites (1)

Hospital de Terrassa

Terrassa, Barcelona, 08225, Spain

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urinary Bladder Diseases

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: April 1, 2014
• Primary Completion: June 2, 2024
• Study Completion: June 2, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)