A Phase II Trial Evaluating an Organ-conserving Strategy by Radiochemotherapy for Muscle-infiltrative Bladder Cancer
Conditions
Infiltrating Bladder Urothelial Carcinoma
Conditions: official terms
Carcinoma, Transitional Cell - Urinary Bladder Neoplasms
Conditions: Keywords
Bladder cancer, Organ-conserving strategy, Radiochemotherapy, non metastatic
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Radiation + cisplatin Type: Other
Name: Radiation + cisplatin + gemcitabine Type: Other
Overall Status
Recruiting
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Muscle invasive urothelial cancer (front line or following the progression of a superficial tumor), pT2-pT3 stage without lymphatic impairment (N0) and without detectable metastases (M0). An optimal macroscopic resection (TURB) have to be performed

- The proof of invasive tumor to the muscle should be brought by a transurethral resection under anaesthesia less than 8 weeks before or, in the absence, by superficial biopsies and formal imaging. Multiples biopsies in the bladder must also be performed.

- Age ≥ 18 years

- Life expectancy ≥ 6 months

- Kanorfsky index ≥ 70 % (WHO 0, 1, 2)

- Biological criteria: neutrophils ≥ 1500/mm3, Platelets ≥ 100 000/mm3, haemoglobin ≥ 10 g/dl, creatinine clearance > 60 ml/mn

- No distant metastases (Thorax, abdomen, and pelvic CT-scan, bone scan)

- Efficient contraception for premenopausal women, maintained during the whole treatment and up to two months after the completion of radiotherapy.

- No radiotherapy or chemotherapy history except for in situ bladder lesions.

- No carcinological history except for non melanoma skin tumours, in situ uterine cervix cancer

- No contraindication to gemcitabine or cisplatin.

- No contraindication to radiotherapy

- Information letter and informed consent signed

- Patient covered by social security

Exclusion Criteria:

- Bladder tumors without any muscle infiltration

- Epidermoid carcinoma or adenocarcinoma

- Distance metastases or extrapelvic node positivity

- Severe digestive history (ulcerative colitis, complicated diverticulitis)

- Pregnancy and breast feeding
Location
CRLC Val d'Aurelle-Paul Lamarque
Montpellier, France
Status: Recruiting
Contact: Jean-Pierre Bleuse, MD - +33 4 67 61 23 44 - Jean-Pierre.Bleuse@montpellier.unicancer.fr
Start Date
September 2011
Completion Date
September 2019
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Source
Institut du Cancer de Montpellier - Val d'Aurelle
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page