A Phase II Trial Evaluating an Organ-conserving Strategy by Radiochemotherapy for Muscle-infiltrative Bladder Cancer — GETUGV04

Infiltrating Bladder Urothelial Carcinoma Clinical Trial

Official title:
A Randomized Phase II Trial Evaluating an Organ-conserving Strategy With Radiotherapy + CDDP + Gemcitabine vs Radiotherapy + CDDP in Muscle-infiltrative Bladder Cancer

Status Active, not recruiting

Clinical Trial Summary

If radical cystectomy remains the standard of care for muscle invasive bladder cancer, consequences of this surgical procedure are often harsh. Over the past years, concurrent chemo-radiotherapy has imposed itself as an alternative treatment. Published data on concomitant radiochemotherapy (radiotherapy/cisplatin or radiotherapy/cisplatin/5-fluorouracil combinations) showed local control rates with bladder preservation at 5 years ranging from 40% to 65% according to the disease stage, and overall survival probabilities ranging from 40% to 50% at 5 years. In order to improve local and systemic prognosis, evaluation of other chemotherapy agents with higher radiosensitizing effect, such as gemcitabine, is justified. Gemcitabine possesses its own anti-cancer activities on urothelial diseases and has a synergetic activity with cisplatin. The investigators completed a monocenter phase I study combining radiotherapy, cisplatin, and twice-weekly gemcitabine, and determined a recommended dose of gemcitabine 25 mg/m². The objective of the present study is to evaluate the combination of radiotherapy + cisplatin + gemcitabine in terms of disease-free survival in non metastatic muscle invasive urothelial cancer patients.

Clinical Trial Description

The objective of the present study is to evaluate the combination of radiotherapy + cisplatin + gemcitabine in terms of disease-free survival in non metastatic muscle invasive urothelial cancer patients. ;

Study Design

Related Conditions & MeSH terms

Infiltrating Bladder Urothelial Carcinoma
Urinary Bladder Neoplasms

Clinical Trial Details

NCT number	NCT01495676
Study type	Interventional
Source	Institut du Cancer de Montpellier - Val d'Aurelle
Contact
Status	Active, not recruiting
Phase	N/A
Start date	July 6, 2011
Completion date	September 2025

View Details

See also
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Withdrawn	`NCT03419130` - Radiation Therapy and Pembrolizumab in Treating Patients With Localized Urothelial Bladder Cancer	Phase 2
Withdrawn	`NCT03238664` - Robot-Assisted Laparoscopic High-Intensity Focused Ultrasound and Radical Cystectomy for Thermal Ablation of Muscle Invasive Cells in Patients With Bladder Tumors	N/A
Active, not recruiting	`NCT03549715` - NEoadjuvant Dose-dense MVAC In cOmbination With Durvalumab and Tremelimumab in Muscle-invasive Urothelial Carcinoma	Phase 1/Phase 2
Terminated	`NCT02767921` - sEphB4-HSA Before Surgery in Treating Patients With Bladder Cancer, Prostate Cancer, or Kidney Cancer	Phase 1
Recruiting	`NCT03609216` - Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations	Phase 2
Withdrawn	`NCT02688348` - Quality of Life After Bladder-Preservation Chemotherapy and Radiation Therapy in Patients With Muscle-Invasive Bladder Cancer	N/A