A Phase II Trial Evaluating an Organ-conserving Strategy by Radiochemotherapy for Muscle-infiltrative Bladder Cancer
NCT ID: NCT01495676
Last Updated: 2025-10-10
Study Results
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View full resultsBasic Information
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TERMINATED
NA
69 participants
INTERVENTIONAL
2011-07-06
2024-12-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiotherapy + cisplatin
Radiation + cisplatin
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.
Radiotherapy + cisplatin + gemcitabine
Radiation + cisplatin + gemcitabine
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.
Interventions
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Radiation + cisplatin
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.
Radiation + cisplatin + gemcitabine
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Epidermoid carcinoma or adenocarcinoma
* Distance metastases or extrapelvic node positivity
* Severe digestive history (ulcerative colitis, complicated diverticulitis)
* Pregnancy and breast feeding
18 Years
ALL
No
Sponsors
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Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Responsible Party
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Principal Investigators
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Azria David, MD
Role: STUDY_CHAIR
ICM Val d'Aurelle
Locations
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Institut Bergonié
Bordeaux, , France
Centre Francois Baclesse
Caen, , France
Hopital Henri Mondor
Créteil, , France
CRLC GF Leclerc
Dijon, , France
CRLC Val d'Aurelle-Paul Lamarque
Montpellier, , France
Centre azuréen de Cancérologie
Mougins, , France
Centre Antoine Lacassagne
Nice, , France
Hopital saint Louis
Paris, , France
HEGP
Paris, , France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, , France
Clinique Patseur
Toulouse, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Countries
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References
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Azria D, Jacot W, Prost P, Culine S, Ychou M, Lemanski C, Dubois JB. [Gemcitabine and ionizing radiations: radiosensitization or radio-chemotherapy combination]. Bull Cancer. 2002 Apr;89(4):369-79. French.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2011-000408-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GETUG V04
Identifier Type: -
Identifier Source: org_study_id
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