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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000408-17 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy + cisplatin | Active Comparator |
| |
| Radiotherapy + cisplatin + gemcitabine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation + cisplatin | Other | 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.
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival | 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. Patients without relapse and living at 2 years will be considered a success | Two years after the end of the complete therapeutic sequence |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 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. | Up to 5 years |
| Acute and Late Toxicities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Azria David, MD | ICM Val d'Aurelle | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | 33000 | France | |||
| Centre Francois Baclesse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12016038 | Background | 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. | |
| 14630267 | Background | Caffo O, Fellin G, Graffer U, Valduga F, Bolner A, Luciani L, Tomio L, Galligioni E. Phase I study of gemcitabine and radiotherapy plus cisplatin after transurethral resection as conservative treatment for infiltrating bladder cancer. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1310-6. doi: 10.1016/s0360-3016(03)00763-6. |
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Individual data are listed in the form of datalistings (lists by chapter) and "patient profile" (summary of main data per patient). The database is frozen for validated data. This basic freezing is done by the dated copy of the database and then by a selection of observations meeting the criteria. This process is repeated until the complete recovery of the validated data.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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.
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 22, 2020 |
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|
| Radiation + cisplatin + gemcitabine | Other | 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. |
|
Acute and late toxicities will be scored according to the NCI-CTC v4.0. Grade 0 : no toxicity Grade 4 : worse toxicity
| Up to 5 years |
| Correlation Between Lymphocyte Apoptosis and Severity of Late Toxicities. | 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. Percentage of Cell Death Measured by Apoptosis This Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention | Up to 5 years |
| Caen |
| 14000 |
| France |
| Hopital Henri Mondor | Créteil | 94010 | France |
| CRLC GF Leclerc | Dijon | 21000 | France |
| CRLC Val d'Aurelle-Paul Lamarque | Montpellier | 34000 | France |
| Centre azuréen de Cancérologie | Mougins | 06250 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Hopital saint Louis | Paris | 75010 | France |
| HEGP | Paris | 75015 | France |
| Institut de Cancérologie Lucien Neuwirth | Saint-Priest-en-Jarez | 42705 | France |
| Clinique Patseur | Toulouse | 31300 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| 8808849 | Background | Chauvet B, Brewer Y, Felix-Faure C, Davin JL, Choquenet C, Reboul F. Concurrent cisplatin and radiotherapy for patients with muscle invasive bladder cancer who are not candidates for radical cystectomy. J Urol. 1996 Oct;156(4):1258-62. |
| 9868392 | Background | Chauvet B, Davin JL, Alfonsi M, Berger C, Vincent P, Reboul F. [Conservative treatment of bladder cancers with radiotherapy and concurrent chemotherapy: results and perspectives]. Cancer Radiother. 1998 Sep-Oct;2(5):499-504. doi: 10.1016/s1278-3218(98)80058-9. French. |
| 21205754 | Background | Choudhury A, Swindell R, Logue JP, Elliott PA, Livsey JE, Wise M, Symonds P, Wylie JP, Ramani V, Sangar V, Lyons J, Bottomley I, McCaul D, Clarke NW, Kiltie AE, Cowan RA. Phase II study of conformal hypofractionated radiotherapy with concurrent gemcitabine in muscle-invasive bladder cancer. J Clin Oncol. 2011 Feb 20;29(6):733-8. doi: 10.1200/JCO.2010.31.5721. Epub 2011 Jan 4. |
| 7928455 | Background | Dunst J, Sauer R, Schrott KM, Kuhn R, Wittekind C, Altendorf-Hofmann A. Organ-sparing treatment of advanced bladder cancer: a 10-year experience. Int J Radiat Oncol Biol Phys. 1994 Sep 30;30(2):261-6. doi: 10.1016/0360-3016(94)90003-5. |
| 7997706 | Background | Ensign LG, Gehan EA, Kamen DS, Thall PF. An optimal three-stage design for phase II clinical trials. Stat Med. 1994 Sep 15;13(17):1727-36. doi: 10.1002/sim.4780131704. |
| 12597983 | Background | Fechner G, Perabo FG, Schmidt DH, Haase L, Ludwig E, Schueller H, Blatter J, Mller SC, Albers P. Preclinical evaluation of a radiosensitizing effect of gemcitabine in p53 mutant and p53 wild type bladder cancer cells. Urology. 2003 Feb;61(2):468-73. doi: 10.1016/s0090-4295(02)02156-8. |
| 14529770 | Background | Hagan MP, Winter KA, Kaufman DS, Wajsman Z, Zietman AL, Heney NM, Toonkel LM, Jones CU, Roberts JD, Shipley WU. RTOG 97-06: initial report of a phase I-II trial of selective bladder conservation using TURBT, twice-daily accelerated irradiation sensitized with cisplatin, and adjuvant MCV combination chemotherapy. Int J Radiat Oncol Biol Phys. 2003 Nov 1;57(3):665-72. doi: 10.1016/s0360-3016(03)00718-1. |
| 15245938 | Background | Herman JM, Smith DC, Montie J, Hayman JA, Sullivan MA, Kent E, Griffith KA, Esper P, Sandler HM. Prospective quality-of-life assessment in patients receiving concurrent gemcitabine and radiotherapy as a bladder preservation strategy. Urology. 2004 Jul;64(1):69-73. doi: 10.1016/j.urology.2004.02.024. |
| 8229129 | Background | Housset M, Maulard C, Chretien Y, Dufour B, Delanian S, Huart J, Colardelle F, Brunel P, Baillet F. Combined radiation and chemotherapy for invasive transitional-cell carcinoma of the bladder: a prospective study. J Clin Oncol. 1993 Nov;11(11):2150-7. doi: 10.1200/JCO.1993.11.11.2150. |
| 15226322 | Background | Kent E, Sandler H, Montie J, Lee C, Herman J, Esper P, Fardig J, Smith DC. Combined-modality therapy with gemcitabine and radiotherapy as a bladder preservation strategy: results of a phase I trial. J Clin Oncol. 2004 Jul 1;22(13):2540-5. doi: 10.1200/JCO.2004.10.070. |
| 20385453 | Background | Lagrange JL, Bascoul-Mollevi C, Geoffrois L, Beckendorf V, Ferrero JM, Joly F, Allouache N, Bachaud JM, Chevreau C, Kramar A, Chauvet B; Study Group on Genito-Urinary Tumors. Quality of life assessment after concurrent chemoradiation for invasive bladder cancer: results of a multicenter prospective study (GETUG 97-015). Int J Radiat Oncol Biol Phys. 2011 Jan 1;79(1):172-8. doi: 10.1016/j.ijrobp.2009.10.038. Epub 2010 Apr 10. |
| 9815749 | Background | Lawrence TS, Chang EY, Hahn TM, Shewach DS. Delayed radiosensitization of human colon carcinoma cells after a brief exposure to 2',2'-difluoro-2'-deoxycytidine (Gemcitabine). Clin Cancer Res. 1997 May;3(5):777-82. |
| 9396395 | Background | Moore MJ, Tannock IF, Ernst DS, Huan S, Murray N. Gemcitabine: a promising new agent in the treatment of advanced urothelial cancer. J Clin Oncol. 1997 Dec;15(12):3441-5. doi: 10.1200/JCO.1997.15.12.3441. |
| 12118019 | Background | Rodel C, Grabenbauer GG, Kuhn R, Papadopoulos T, Dunst J, Meyer M, Schrott KM, Sauer R. Combined-modality treatment and selective organ preservation in invasive bladder cancer: long-term results. J Clin Oncol. 2002 Jul 15;20(14):3061-71. doi: 10.1200/JCO.2002.11.027. |
| 15667962 | Background | Sangar VK, McBain CA, Lyons J, Ramani VA, Logue JP, Wylie JP, Clarke NW, Cowan RA. Phase I study of conformal radiotherapy with concurrent gemcitabine in locally advanced bladder cancer. Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):420-5. doi: 10.1016/j.ijrobp.2004.05.074. |
| 8205542 | Background | Shewach DS, Hahn TM, Chang E, Hertel LW, Lawrence TS. Metabolism of 2',2'-difluoro-2'-deoxycytidine and radiation sensitization of human colon carcinoma cells. Cancer Res. 1994 Jun 15;54(12):3218-23. |
| 12673704 | Background | Shipley WU, Kaufman DS, Tester WJ, Pilepich MV, Sandler HM; Radiation Therapy Oncology Group. Overview of bladder cancer trials in the Radiation Therapy Oncology Group. Cancer. 2003 Apr 15;97(8 Suppl):2115-9. doi: 10.1002/cncr.11282. |
| 9363871 | Background | Stadler WM, Kuzel T, Roth B, Raghavan D, Dorr FA. Phase II study of single-agent gemcitabine in previously untreated patients with metastatic urothelial cancer. J Clin Oncol. 1997 Nov;15(11):3394-8. doi: 10.1200/JCO.1997.15.11.3394. |
| 11157016 | Background | Stein JP, Lieskovsky G, Cote R, Groshen S, Feng AC, Boyd S, Skinner E, Bochner B, Thangathurai D, Mikhail M, Raghavan D, Skinner DG. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol. 2001 Feb 1;19(3):666-75. doi: 10.1200/JCO.2001.19.3.666. |
| 8558186 | Background | Tester W, Caplan R, Heaney J, Venner P, Whittington R, Byhardt R, True L, Shipley W. Neoadjuvant combined modality program with selective organ preservation for invasive bladder cancer: results of Radiation Therapy Oncology Group phase II trial 8802. J Clin Oncol. 1996 Jan;14(1):119-26. doi: 10.1200/JCO.1996.14.1.119. |
| 12801735 | Background | Advanced Bladder Cancer Meta-analysis Collaboration. Neoadjuvant chemotherapy in invasive bladder cancer: a systematic review and meta-analysis. Lancet. 2003 Jun 7;361(9373):1927-34. doi: 10.1016/s0140-6736(03)13580-5. |
| 9933034 | Background | Vogelzang NJ, Stadler WM. Gemcitabine and other new chemotherapeutic agents for the treatment of metastatic bladder cancer. Urology. 1999 Feb;53(2):243-50. doi: 10.1016/s0090-4295(98)00501-9. |
| 11001674 | Background | von der Maase H, Hansen SW, Roberts JT, Dogliotti L, Oliver T, Moore MJ, Bodrogi I, Albers P, Knuth A, Lippert CM, Kerbrat P, Sanchez Rovira P, Wersall P, Cleall SP, Roychowdhury DF, Tomlin I, Visseren-Grul CM, Conte PF. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol. 2000 Sep;18(17):3068-77. doi: 10.1200/JCO.2000.18.17.3068. |
| 41690405 | Derived | Michalet M, Ronchin P, Reynaud T, Demogeot N, Gourgou S, Thezenas S, Hannoun-Levi JM, Salem N, Quivrin M, Riou O, Charissoux M, Llacer-Moscardo C, Tosi D, Durdux C, Khalladi N, Culine S, Azria D. Radiotherapy with twice weekly Gemcitabine and Cisplatin compared to Cisplatin alone for organ preservation in muscle-invasive bladder cancer: results of the GETUG V04 randomized phase II trial. Radiother Oncol. 2026 Apr;217:111443. doi: 10.1016/j.radonc.2026.111443. Epub 2026 Feb 12. |
| 24368064 | Derived | Azria D, Riou O, Rebillard X, Thezenas S, Thuret R, Fenoglietto P, Pouessel D, Culine S. Combined chemoradiation therapy with twice-weekly gemcitabine and cisplatin for organ preservation in muscle-invasive bladder cancer: long-term results of a phase 1 trial. Int J Radiat Oncol Biol Phys. 2014 Mar 15;88(4):853-9. doi: 10.1016/j.ijrobp.2013.11.016. Epub 2013 Dec 21. |
| FG001 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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.
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Disease-free Survival | 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. Patients without relapse and living at 2 years will be considered a success | Posted | Count of Participants | Participants | Two years after the end of the complete therapeutic sequence |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | 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. | Posted | Count of Participants | Participants | Up to 5 years |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Acute and Late Toxicities | Acute and late toxicities will be scored according to the NCI-CTC v4.0. Grade 0 : no toxicity Grade 4 : worse toxicity | Analyses are performed on the population that can be evaluated for tolerance | Posted | Count of Participants | Participants | Up to 5 years |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between Lymphocyte Apoptosis and Severity of Late Toxicities. | 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. Percentage of Cell Death Measured by Apoptosis This Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention | patient groups were defined in order to validate a possible correlation between the apoptosis rate observed during blood analysis and the severe toxicity rate. | Posted | Mean | Standard Deviation | Percentage of dead Cells | Up to 5 years |
|
collection from the baseline to 5 years afetr the treatment
Analyses are performed on the population assessable for tolerance, 24 vs 43 pts in the arms RT/CDDP and RT/CDDP/GEMZAR; Two pts RT/CDDP/GEMAZR having not treated.
only toxicities are discussed in Probable/Possible relationship with treatment. All patients reported at least toxicity. Two patients showed no toxicity his Outcome Measure was pre-specified to report based on toxicity event instead of assigned intervention", or similar, as accurate and appropriate
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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.
| 7 | 24 | 9 | 24 | 24 | 24 |
| EG001 | 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. | 20 | 45 | 23 | 45 | 45 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| thrombopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| large instestinal stenosis | Gastrointestinal disorders | Systematic Assessment |
| ||
| small instestinal obtstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| asthenia | General disorders | Systematic Assessment |
| ||
| radiation proctitis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| gastroenteritis radiation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| sepsis | Infections and infestations | Systematic Assessment |
| ||
| acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| hematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| atrial flutter | Cardiac disorders | Systematic Assessment |
| ||
| streptococcal sepsis | Infections and infestations | Systematic Assessment |
| ||
| adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| lip squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| completed suicide | Psychiatric disorders | Systematic Assessment |
| ||
| acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| hypertension | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| alopecia | General disorders | Systematic Assessment | grade 2 |
| |
| anorexia | Gastrointestinal disorders | Systematic Assessment | Grade 1 to 3 |
| |
| Asthenia | General disorders | Systematic Assessment | grade 1 to 3 |
| |
| Other toxicity | General disorders | Systematic Assessment | grade 1 to 4 |
| |
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | grade 1 to 3 |
| |
| abdominal pain | Gastrointestinal disorders | Systematic Assessment | grade 1 and 2 |
| |
| dysgueusia | General disorders | Systematic Assessment | grade 1 and 2 |
| |
| dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | grade 1 |
| |
| dysuria | Renal and urinary disorders | Systematic Assessment | grade 1 and 2 |
| |
| fever | Infections and infestations | Systematic Assessment | grade 1 to 4 |
| |
| hematuria | Renal and urinary disorders | Systematic Assessment | grade 1 to 3 |
| |
| infection | Infections and infestations | Systematic Assessment | grade 2 and 4 |
| |
| urinary infection | Infections and infestations | Systematic Assessment | grade 1 and 2 |
| |
| mucocitis | Skin and subcutaneous tissue disorders | Systematic Assessment | grade 1 |
| |
| nausea | Gastrointestinal disorders | Systematic Assessment | grade 1 and 2 |
| |
| neuropathy | Nervous system disorders | Systematic Assessment | grade 1 |
| |
| pollakiuria | Renal and urinary disorders | Systematic Assessment | grade 1 to 3 |
| |
| audition toxicity | Ear and labyrinth disorders | Systematic Assessment | grade 1 and 2 |
| |
| vomiting | Gastrointestinal disorders | Systematic Assessment | grade 1 and 2 |
|
no data for Measurement of Quality of Life
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mme Aurore Moussion, Director of Direction of Clinical Research and Innovation | INSTITUT REGIONAL DU CANCER DE MONTPELLIER | 0467613102 | +33 | drci-icm105@icm.unicancer.fr |
| Feb 4, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011827 | Radiation |
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
|
|
|
|
|
|
| OG003 |
| Patients With Severe Toxicity (Acute and Late) |
patient with acute and late severe toxicity |
|
|