Infiltrating Bladder Urothelial CarcinomaGETUGV04NCT01495676
A Phase II Trial Evaluating an Organ-conserving Strategy by Radiochemotherapy for Muscle-infiltrative Bladder Cancer
A study testing Radiation + cisplatin and Radiation + cisplatin + gemcitabine in people with Infiltrating Bladder Urothelial Carcinoma, run by Institut du Cancer de Montpellier - Val d'Aurelle at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infiltrating Bladder Urothelial Carcinoma
- What is being tested?
- Radiation + cisplatin and Radiation + cisplatin + gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 12 sitesFrance
- Study dates
- 6 Jul 2011to 7 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Institut Bergonié
Bordeaux, 33000
Centre Francois Baclesse
Caen, 14000
Hopital Henri Mondor
Créteil, 94010
CRLC GF Leclerc
Dijon, 21000
CRLC Val d'Aurelle-Paul Lamarque
Montpellier, 34000
Centre azuréen de Cancérologie
Mougins, 06250
Centre Antoine Lacassagne
Nice, 06189
Hopital saint Louis
Paris, 75010
HEGP
Paris, 75015
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42705
Clinique Patseur
Toulouse, 31300
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
About this study
Official title: A Randomized Phase II Trial Evaluating an Organ-conserving Strategy With Radiotherapy + CDDP + Gemcitabine vs Radiotherapy + CDDP in Muscle-infiltrative Bladder Cancer
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.
Read the 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.
- Being tested
- Radiation + cisplatin, Radiation + cisplatin + gemcitabine
- Keywords
- Bladder cancer, Organ-conserving strategy, Radiochemotherapy, non metastatic
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation + cisplatinOther
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 + gemcitabineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy + cisplatin | Active comparator | Not described Receives: Other: Radiation + cisplatin |
| Radiotherapy + cisplatin + gemcitabine | Experimental | Not described Receives: Other: Radiation + cisplatin + gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Two years after the end of the complete therapeutic sequence
Secondary outcomes (3)
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.
Measured: Up to 5 years
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
Measured: 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
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
- Study start6 Jul 2011
- Primary completion25 Jul 2022
- Study completion7 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Infiltrating Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Azria David, MD, Study chair, ICM Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495676
- Sponsor's protocol ID
- GETUG V04
- Other IDs
- 2011-000408-17
- Acronym
- GETUGV04
- Status last verified
- Jul 2025
- First submitted
- 14 Dec 2011
- Last updated
- 10 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 12016038Caffo 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.
PubMed 14630267Chauvet 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.
PubMed 8808849Chauvet 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.
PubMed 9868392Choudhury 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.
PubMed 21205754Dunst 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.
PubMed 7928455Ensign 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.
PubMed 7997706Fechner 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.
PubMed 12597983Hagan 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.
PubMed 14529770Herman 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.
PubMed 15245938Housset 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.
PubMed 8229129Kent 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.
PubMed 15226322Lagrange 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.
PubMed 20385453Lawrence 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.
PubMed 9815749Moore 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.
PubMed 9396395
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial Evaluating an Organ-conserving Strategy With Radiotherapy + CDDP + Gemcitabine vs Radiotherapy + CDDP in Muscle-infiltrative Bladder Cancer
- ClinicalTrials.gov ID
- NCT01495676
- Acronym / sponsor ID
- GETUGV04 / GETUG V04
- Keywords
- Bladder cancer, Organ-conserving strategy, Radiochemotherapy, non metastatic
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 6 Jul 2011 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 7 Dec 2024 (actual)
- First posted
- 20 Dec 2011 (estimated)
- Results
- Posted 10 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy + cisplatin | Active comparator | Other: Radiation + cisplatin |
| Radiotherapy + cisplatin + gemcitabine | Experimental | Other: Radiation + cisplatin + gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation + cisplatinRT 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. | Other | Radiotherapy + cisplatin |
| Radiation + cisplatin + gemcitabineRadiotherapy 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. | Other | Radiotherapy + cisplatin + gemcitabine |
Primary outcome
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. Patients without relapse and living at 2 years will be considered a success
3 secondary outcomes
Overall Survival
Time frame: Up to 5 years
Acute and Late Toxicities
Time frame: Up to 5 years
Correlation Between Lymphocyte Apoptosis and Severity of Late Toxicities.
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12016038Azria 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.
- Background: PubMed 14630267Caffo 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.
- Background: PubMed 8808849Chauvet 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.
- Background: PubMed 9868392Chauvet 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.
- Background: PubMed 21205754Choudhury 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.
- Background: PubMed 7928455Dunst 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.
- Background: PubMed 7997706Ensign 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.
- Background: PubMed 12597983Fechner 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.
- Background: PubMed 14529770Hagan 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.
- Background: PubMed 15245938Herman 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.
- Background: PubMed 8229129Housset 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.
- Background: PubMed 15226322Kent 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azria David, MD study chair
ICM Val d'Aurelle
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation + cisplatin and Radiation + cisplatin + gemcitabine in people with Infiltrating Bladder Urothelial Carcinoma, run by Institut du Cancer de Montpellier - Val d'Aurelle at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free Survival (time frame: Two years after the end of the complete therapeutic sequence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01495676, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.