A Phase II Trial Evaluating an Organ-conserving Strategy by Radiochemotherapy for Muscle-infiltrative Bladder Cancer (GETUGV04)
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|ClinicalTrials.gov Identifier: NCT01495676|
Recruitment Status : Recruiting
First Posted : December 20, 2011
Last Update Posted : August 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infiltrating Bladder Urothelial Carcinoma||Other: Radiation + cisplatin Other: Radiation + cisplatin + gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Trial Evaluating an Organ-conserving Strategy With Radiotherapy + CDDP + Gemcitabine vs Radiotherapy + CDDP in Muscle-infiltrative Bladder Cancer|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2020|
U.S. FDA Resources
|Active Comparator: Radiotherapy + cisplatin||
Other: 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.
|Experimental: Radiotherapy + cisplatin + gemcitabine||
Other: 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.
- Disease-free survival [ Time Frame: Two years after the end of the complete therapeutic sequence ]The time to relapse is defined as the time from the date of randomisation to the date of the first event. Time to relapse for patients without any event (local, regional, distance, or death) will be censored at the date of latest information.
- Overall survival [ Time Frame: Up to 5 years ]The time to death is defined as time from the randomization to the date of death from any cause, or to the date on which latest information is obtained.
- Acute and late toxicities [ Time Frame: Up to 5 years ]Acute and late toxicities will be scored according to the NCI-CTC v4.0.
- Quality of life [ Time Frame: Up to 5 years ]Questionnaires QLQ C30 + QLQ-BLM30 + QLQ-ELD15 + Oncodage
- Correlation between lymphocyte apoptosis and severity of late toxicities. [ Time Frame: Up to 5 years ]Before starting radiotherapy, 5ml of blood will be sampled in a 5ml heparinised tube to prospectively measure the rate of CD8 radio-induced lymphocyte apoptosis before any radiotherapy treatment. A correlation between the low rate of lymphocyte apoptosis and the severity of late toxicities will be studied to confirm the predictive power of this biological test on radio-induced side-effects.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495676
|Contact: David Azria, MD., Ph D||+33 4 67 61 31 35||David.Azria@montpellier.unicancer.fr|
|CRLC Val d'Aurelle-Paul Lamarque||Recruiting|
|Montpellier, France, 34000|
|Contact: Jean-Pierre Bleuse, MD +33 4 67 61 23 44 Jean-Pierre.Bleuse@montpellier.unicancer.fr|
|Principal Investigator: David Azria, MD, Ph D|