Trial Title:
A Phase II Trial Evaluating an Organ-conserving Strategy by Radiochemotherapy for Muscle-infiltrative Bladder Cancer
NCT ID:
NCT01495676
Condition:
Infiltrating Bladder Urothelial Carcinoma
Conditions: Official terms:
Urinary Bladder Neoplasms
Cisplatin
Gemcitabine
Conditions: Keywords:
Bladder cancer
Organ-conserving strategy
Radiochemotherapy
non metastatic
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Radiation + cisplatin
Description:
RT will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 if an additional treatment is decided.
A cystoscopy with a transurethral resection will be performed 3 weeks after the last day of the first part of radio-chemotherapy.
In the absence of tumor cells, the 2nd part will start on the 4th week or at latest on the 5th week after the last day of the 1st part of radio-chemotherapy.
In case of a microscopic tumor residue or of a local tumor progression, operability will be re-evaluated in view of a radical cystectomy and the patient will exit the study.
Arm group label:
Radiotherapy + cisplatin
Intervention type:
Other
Intervention name:
Radiation + cisplatin + gemcitabine
Description:
Radiotherapy will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 for the second part of the treatment if an additional treatment is decided.
Gemcitabine: iv injection for 30 minutes, twice a week at a dose of 25 mg/m2 on days 2, 5, 9, 12, 16, 19, 23, 26, 30, and 33 for the 1st part of treatment, then on days 2, 5, 9, and 12 for the 2nd part of treatment if an additional treatment is decided (cystoscopy with a transurethral resection). RT will be delivered between 2 and 6 hours after completion of the gemcitabine injection.
Arm group label:
Radiotherapy + cisplatin + gemcitabine
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:
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Bergonié
Address:
City:
Bordeaux
Zip:
33000
Country:
France
Facility:
Name:
Centre Francois Baclesse
Address:
City:
Caen
Zip:
14000
Country:
France
Facility:
Name:
Hopital Henri Mondor
Address:
City:
Créteil
Zip:
94010
Country:
France
Facility:
Name:
CRLC GF Leclerc
Address:
City:
Dijon
Zip:
21000
Country:
France
Facility:
Name:
CRLC Val d'Aurelle-Paul Lamarque
Address:
City:
Montpellier
Zip:
34000
Country:
France
Facility:
Name:
Centre azuréen de Cancérologie
Address:
City:
Mougins
Zip:
06250
Country:
France
Facility:
Name:
Centre Antoine Lacassagne
Address:
City:
Nice
Zip:
06189
Country:
France
Facility:
Name:
Hopital saint Louis
Address:
City:
Paris
Zip:
75010
Country:
France
Facility:
Name:
HEGP
Address:
City:
Paris
Zip:
75015
Country:
France
Facility:
Name:
Institut de Cancérologie Lucien Neuwirth
Address:
City:
Saint-Priest-en-Jarez
Zip:
42705
Country:
France
Facility:
Name:
Clinique Patseur
Address:
City:
Toulouse
Zip:
31300
Country:
France
Facility:
Name:
Centre Alexis Vautrin
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54511
Country:
France
Start date:
July 6, 2011
Completion date:
September 2025
Lead sponsor:
Agency:
Institut du Cancer de Montpellier - Val d'Aurelle
Agency class:
Other
Source:
Institut du Cancer de Montpellier - Val d'Aurelle
Record processing date:
ClinicalTrials.gov processed this data on April 10, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01495676
