Evaluation of the Clinical Utility of Online Adaptive Radiotherapy in Bladder Cancer (BLADAPT-GETUG V11)

NCT ID: NCT07043543

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2033-09-30

Brief Summary

Trimodal therapy (TMT) consisting of transurethral resection of bladder tumors followed by radiotherapy and chemotherapy is a therapeutic alternative in patients with Muscle-Infiltrating Bladder Cancer who are inoperable or refuse surgery. One of the main challenges of TMT is the planning and delivery of radiation therapy. Indeed, the bladder is a mobile hollow organ subject to repletion, with variations in size and shape during and between radiotherapy sessions. Standard radiotherapy techniques require large planning target volume margins around the bladder, which can be responsible for irradiation of a large volume of large and small bowel with grade 2 and 3 toxicities.

Adaptive radiotherapy allows for the generation of a treatment fraction personalized to a patient's anatomical modification with margin reduction and improves the dosimetric quality of the delivered plans.

The hypothesis is that this improvement results in radiation-induced toxicity improvement.

Detailed Description

In 2023, the incidence of muscle-infiltrating bladder cancer (MIBC) in France was 14062 cases, 81% of which were in men.

The standard treatment for MIBC is cystectomy preceded by neoadjuvant chemotherapy. Trimodal therapy (TMT), consisting of transurethral resection of bladder tumors (TURBT) followed by radiotherapy (RT) and chemotherapy (CT), has emerged as a valuable therapeutic de-escalation alternative in patients who are inoperable or refuse surgery with its physical and psychological sequelae. TMT provides survival outcomes identical to cystectomy in selected patients and allows for bladder preservation in successful cases. TMT is an effective potential alternative to radical cystectomy for recurrent high-grade T1 urothelial cancer of the bladder who failed intravesical therapy.

One of the main challenges of TMT is the planning and delivery of radiation therapy. Indeed, the bladder is a mobile hollow organ subject to repletion, with variations in size and shape during radiotherapy sessions (intra-fractional movement) and between sessions (inter-fractional movement). To take into account these movements, standard radiotherapy techniques require large planning target volume (PTV) margins around the bladder, which can be responsible for irradiation of a large volume of large and small bowel with grade 2 and 3 toxicities up to 42% and 17% respectively.

Adaptive radiotherapy (ART) allows for the generation of a treatment fraction personalized to a patient's anatomical modification. While it was until recently only performed "offline", i.e. between two radiotherapy sessions, it is now possible to perform a daily customization of the radiotherapy session ("online") for a given patient to ensure optimal coverage of the target with minimized margins. ART allows PTV margins reduction for MIBC and improves therefore the dosimetric quality of the delivered plans.

The hypothesis is that the dosimetric improvement induced by ART results in radiation-induced toxicity improvement.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental arm

Adaptive radiotherapy +/- chemotherapy

Group Type: EXPERIMENTAL

Adaptive radiotherapy

Intervention Type: RADIATION

Patient will be treated by concomitant:

• adaptive radiotherapy 5 days a week for 4 weeks with hypofractionated irradiation 55 Gy / 20 fractions +/- pelvic inclusion 44 Gy/20 fractions (SIB).
• chemotherapy if not contraindicated :

• Cisplatin : 20 mg/m2/day on day 1 to day 4 and day 22 to day 25 (or 80 mg/m2 during week 1 and 4 of radiotherapy) Or
• Gemcitabine: 80 to 100 mg/m2/week Or
• Mitomycin C: 12 mg/m2 on day 1 only + 5FU infusion 500 mg/m2/day during 5 days on week 1 and 4 of radiotherapy (alternatively : capecitabine taken twice daily at a dose of 825 per square meter per day on the days of radiotherapy)

standard arm

Standard radiotherapy +/- chemotherapy

Group Type: ACTIVE_COMPARATOR

standard radiotherapy

Intervention Type: RADIATION

Patient will be treated by concomitant:

• standard 5 days a week for 4 weeks with hypofractionated irradiation 55 Gy / 20 fractions +/- pelvic inclusion 44 Gy/20 fractions (SIB).
• chemotherapy if not contraindicated :

• Cisplatin : 20 mg/m2/day on day 1 to day 4 and day 22 to day 25 (or 80 mg/m2 during week 1 and 4 of radiotherapy) Or
• Gemcitabine: 80 to 100 mg/m2/week Or
• Mitomycin C: 12 mg/m2 on day 1 only + 5FU infusion 500 mg/m2/day during 5 days on week 1 and 4 of radiotherapy (alternatively : capecitabine taken twice daily at a dose of 825 per square meter per day on the days of radiotherapy)

Interventions

Adaptive radiotherapy

Patient will be treated by concomitant:

• adaptive radiotherapy 5 days a week for 4 weeks with hypofractionated irradiation 55 Gy / 20 fractions +/- pelvic inclusion 44 Gy/20 fractions (SIB).
• chemotherapy if not contraindicated :

• Cisplatin : 20 mg/m2/day on day 1 to day 4 and day 22 to day 25 (or 80 mg/m2 during week 1 and 4 of radiotherapy) Or
• Gemcitabine: 80 to 100 mg/m2/week Or
• Mitomycin C: 12 mg/m2 on day 1 only + 5FU infusion 500 mg/m2/day during 5 days on week 1 and 4 of radiotherapy (alternatively : capecitabine taken twice daily at a dose of 825 per square meter per day on the days of radiotherapy)

Intervention Type: RADIATION

standard radiotherapy

Patient will be treated by concomitant:

• standard 5 days a week for 4 weeks with hypofractionated irradiation 55 Gy / 20 fractions +/- pelvic inclusion 44 Gy/20 fractions (SIB).
• chemotherapy if not contraindicated :

• Cisplatin : 20 mg/m2/day on day 1 to day 4 and day 22 to day 25 (or 80 mg/m2 during week 1 and 4 of radiotherapy) Or
• Gemcitabine: 80 to 100 mg/m2/week Or
• Mitomycin C: 12 mg/m2 on day 1 only + 5FU infusion 500 mg/m2/day during 5 days on week 1 and 4 of radiotherapy (alternatively : capecitabine taken twice daily at a dose of 825 per square meter per day on the days of radiotherapy)

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Histologically proven muscle-infiltrating bladder cancer (de novo MIBC or after a history of non-muscle-invasive bladder cancer) or patients with initial high-grade T1 tumor showing Ta or T1 recurrence, or those with high-grade T1 after a course of intravesical biological therapy or chemotherapy;
• Age ≥ 18 years;
• Urothelial carcinoma (transitional cell carcinoma of the bladder, micropapillary, microcystic with trophoblastic differenciation) and squamous cell histological types are allowed;
• Stage T1-T4aN0M0
• TransUrethral Resection of Bladder Tumor (TURBT) and Position Emission Tomography- scanner and X-ray Computed Tomography (PET-CT) or Computed Tomography scan of thorax/abdomen/pelvis (without carcinological anomaly) within 8 weeks prior to the start of radiation therapy (if TURBT was performed more than 6 weeks before the inclusion visit, a new TURBT or, at least, a cystoscopy showing no progression, no residual tumour or regrowth must be done);
• Suitable for radiotherapy;
• Eastern Cooperative Oncology Group/World Human Organisation (ECOG/WHO) performance status from 0 to 2
• Negative pregnancy test (blood or urine), for women of childbearing age only;
• If the patient is sexually active, he/she must agree to use contraception deemed adequate and appropriate by the investigator throughout the period of study drug administration and 6 months after the end of treatment for both men and women.
• Affiliation to the French Social Security System;
• Dated, written and signed Informed consent

Exclusion Criteria

• Prior pelvic radiation therapy;
• Patients with previous or concomitant other malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years;
• Presence of endopenic stent;
• Inability to comply with the protocol;
• Grade 1 or greater baseline diarrhea;
• Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease);
• Uncontrolled immune or cardiac or pulmonary disease;
• Patients whose regular follow-up is impossible for psychological, family, social or geographical reasons;
• Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study;
• Pregnant or breast-feeding subjects

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ligue contre le cancer, France

OTHER

Sponsor Role: collaborator

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier RIOU, MD

Role: PRINCIPAL_INVESTIGATOR

INSTITUT REGIONAL DU CANCER DE MONTPELLIER

Locations

Centre Georges François Leclerc

Dijon, Côte d'or, France

Institut du Cancer de Montpellier

Montpellier, Herault, France

Centre Eugène Marquis

Rennes, Ille et Vilaine, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, Loire Atlantique, France

Centre Oscar Lambret

Lille, Nord, France

Centre de radiothérapie Bayard

Villeurbanne, Rhone, France

Centre Henri Becquerel

Rouen, Seine Maritime, France

Institut Sainte Catherine

Avignon, Var, France

Centre de radiothérapie Saint-Louis

Toulon, Var, France

Hôpital Tenon

Paris, Île-de-France Region, France

Institut Curie

Saint-Cloud, Île-de-France Region, France

Countries

France

Central Contacts

Aurore MOUSSION

Role: CONTACT

aurore.moussion@icm.unicancer.fr

467613102 ext. +33

Facility Contacts

Magalie QUIVRIN, MD

Role: primary

mquivrin@cgfl.fr

0380737518 ext. +33

Olivier RIOU, MD

Role: primary

olivier.riou@icm.unicancer.fr

0467612443 ext. +33

Ingrid MASSON, MD

Role: primary

i.masson@rennes.unicancer.fr

Stéphane SUPIOT, MD

Role: primary

stephane.supiot@ico.unicancer.fr

0240679913 ext. +33

David PASQUIER, MD

Role: primary

d-pasquier@o-lambret.fr

Victor PASSERAT, MD

Role: primary

passerat.bayard@orange.fr

0426686767 ext. +33

Ahmed BENYOUCEF, MD

Role: primary

ahmed.benyoucef@chb.unicancer.fr

Nathalie ROUARD, MD

Role: primary

n.rouard@isc84.org

0490276233 ext. +33

thomas DUBERGE, MD

Role: primary

tduberge@yahoo.fr

0494244050 ext. +33

Laurie MONNIER, MD

Role: primary

laurie.monnier@aphp.fr

0142496059 ext. +33

Gilles CREHANGE, MD

Role: primary

gilles.crehange@curie.fr

References

Cabaille M, Khalifa J, Tessier AM, Belhomme S, Crehange G, Sargos P. [A review of adaptive radiotherapy for bladder cancer]. Cancer Radiother. 2021 May;25(3):271-278. doi: 10.1016/j.canrad.2020.08.046. Epub 2021 Jan 2. French.

Reference Type: BACKGROUND

PMID: 33402293 (View on PubMed)

Fahmy O, Khairul-Asri MG, Schubert T, Renninger M, Malek R, Kubler H, Stenzl A, Gakis G. A systematic review and meta-analysis on the oncological long-term outcomes after trimodality therapy and radical cystectomy with or without neoadjuvant chemotherapy for muscle-invasive bladder cancer. Urol Oncol. 2018 Feb;36(2):43-53. doi: 10.1016/j.urolonc.2017.10.002. Epub 2017 Nov 6.

Reference Type: BACKGROUND

PMID: 29102254 (View on PubMed)

Huddart R, Hafeez S, Omar A, Alonzi R, Birtle A, Cheung KC, Choudhury A, Foroudi F, Gribble H, Henry A, Hilman S, Hindson B, Lewis R, Muthukumar D, McLaren DB, McNair H, Nikapota A, Olorunfemi A, Parikh O, Philipps L, Rimmer Y, Syndikus I, Tolentino A, Varughese M, Vassallo-Bonner C, Webster A, Griffin C, Hall E. Acute Toxicity of Hypofractionated and Conventionally Fractionated (Chemo)Radiotherapy Regimens for Bladder Cancer: An Exploratory Analysis from the RAIDER Trial. Clin Oncol (R Coll Radiol). 2023 Sep;35(9):586-597. doi: 10.1016/j.clon.2023.05.002. Epub 2023 May 9.

Reference Type: BACKGROUND

PMID: 37225552 (View on PubMed)

Hafeez S, Lewis R, Hall E, Huddart R; RAIDER Trial Management Group. Advancing Radiotherapy for Bladder Cancer: Randomised Phase II Trial of Adaptive Image-guided Standard or Dose-escalated Tumour Boost Radiotherapy (RAIDER). Clin Oncol (R Coll Radiol). 2021 Jun;33(6):e251-e256. doi: 10.1016/j.clon.2021.02.012. Epub 2021 Mar 23. No abstract available.

Reference Type: BACKGROUND

PMID: 33766502 (View on PubMed)

Kool R, Dragomir A, Kulkarni GS, Marcq G, Breau RH, Kim M, Busca I, Abdi H, Dawidek M, Uy M, Fervaha G, Cury FL, Alimohamed N, Izawa J, Jeldres C, Rendon R, Shayegan B, Siemens R, Black PC, Kassouf W. Benefit of Neoadjuvant Cisplatin-based Chemotherapy for Invasive Bladder Cancer Patients Treated with Radiation-based Therapy in a Real-world Setting: An Inverse Probability Treatment Weighted Analysis. Eur Urol Oncol. 2024 Dec;7(6):1350-1357. doi: 10.1016/j.euo.2024.01.014. Epub 2024 Feb 6.

Reference Type: BACKGROUND

PMID: 38326142 (View on PubMed)

Dahl DM, Rodgers JP, Shipley WU, Michaelson MD, Wu CL, Parker W, Jani AB, Cury FL, Hudes RS, Michalski JM, Hartford AC, Song D, Citrin DE, Karrison TG, Sandler HM, Feng FY, Efstathiou JA. Bladder-Preserving Trimodality Treatment for High-Grade T1 Bladder Cancer: Results From Phase II Protocol NRG Oncology/RTOG 0926. J Clin Oncol. 2024 Dec;42(34):4095-4102. doi: 10.1200/JCO.23.02510. Epub 2024 Sep 3.

Reference Type: BACKGROUND

PMID: 39226514 (View on PubMed)

de Haar-Holleman A, van Hoogstraten LMC, Hulshof MCCM, Tascilar M, Bruck K; BlaZIB study group; Meijer RP, Alfred Witjes J, Kiemeney LA, Aben KKH. Chemoradiation for muscle-invasive bladder cancer using 5-fluorouracil versus capecitabine: A nationwide cohort study. Radiother Oncol. 2023 Jun;183:109584. doi: 10.1016/j.radonc.2023.109584. Epub 2023 Mar 1.

Reference Type: BACKGROUND

PMID: 36863459 (View on PubMed)

Hall E, Hussain SA, Porta N, Lewis R, Crundwell M, Jenkins P, Rawlings C, Tremlett J, Sreenivasan T, Wallace J, Syndikus I, Sheehan D, Lydon A, Huddart R, James N; BC2001 Investigators. Chemoradiotherapy in Muscle-invasive Bladder Cancer: 10-yr Follow-up of the Phase 3 Randomised Controlled BC2001 Trial. Eur Urol. 2022 Sep;82(3):273-279. doi: 10.1016/j.eururo.2022.04.017. Epub 2022 May 14.

Reference Type: BACKGROUND

PMID: 35577644 (View on PubMed)

Sibolt P, Andersson LM, Calmels L, Sjostrom D, Bjelkengren U, Geertsen P, Behrens CF. Clinical implementation of artificial intelligence-driven cone-beam computed tomography-guided online adaptive radiotherapy in the pelvic region. Phys Imaging Radiat Oncol. 2020 Dec 18;17:1-7. doi: 10.1016/j.phro.2020.12.004. eCollection 2021 Jan.

Reference Type: BACKGROUND

PMID: 33898770 (View on PubMed)

Hussain MH, Glass TR, Forman J, Sakr W, Smith DC, Al-Sarraf M, Jones J, Balcerzak SP, Crawford ED, Grossman HB. Combination cisplatin, 5-fluorouracil and radiation therapy for locally advanced unresectable or medically unfit bladder cancer cases: a Southwest Oncology Group Study. J Urol. 2001 Jan;165(1):56-60; discussion 60-1. doi: 10.1097/00005392-200101000-00014.

Reference Type: BACKGROUND

PMID: 11125363 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24368064 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8229129 (View on PubMed)

Oh KS, Soto DE, Smith DC, Montie JE, Lee CT, Sandler HM. Combined-modality therapy with gemcitabine and radiation therapy as a bladder preservation strategy: long-term results of a phase I trial. Int J Radiat Oncol Biol Phys. 2009 Jun 1;74(2):511-7. doi: 10.1016/j.ijrobp.2008.08.021. Epub 2008 Oct 30.

Reference Type: BACKGROUND

PMID: 18977098 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15226322 (View on PubMed)

Caffo O, Thompson C, De Santis M, Kragelj B, Hamstra DA, Azria D, Fellin G, Pappagallo GL, Galligioni E, Choudhury A. Concurrent gemcitabine and radiotherapy for the treatment of muscle-invasive bladder cancer: A pooled individual data analysis of eight phase I-II trials. Radiother Oncol. 2016 Nov;121(2):193-198. doi: 10.1016/j.radonc.2016.09.006. Epub 2016 Oct 5.

Reference Type: BACKGROUND

PMID: 27720221 (View on PubMed)

Bruck K, Meijer RP, Boormans JL, Kiemeney LA, Witjes JA, van Hoogstraten LMC, van der Heijden MS, Donders AR, Franckena M, Uyl de Groot CA, Leliveld AM, Aben KKH, Hulshof MCCM. Disease-Free Survival of Patients With Muscle-Invasive Bladder Cancer Treated With Radical Cystectomy Versus Bladder-Preserving Therapy: A Nationwide Study. Int J Radiat Oncol Biol Phys. 2024 Jan 1;118(1):41-49. doi: 10.1016/j.ijrobp.2023.07.027. Epub 2023 Jul 28.

Reference Type: BACKGROUND

PMID: 37517601 (View on PubMed)

Pfister C, Gravis G, Flechon A, Chevreau C, Mahammedi H, Laguerre B, Guillot A, Joly F, Soulie M, Allory Y, Harter V, Culine S; VESPER Trial Investigators. Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin or Gemcitabine and Cisplatin as Perioperative Chemotherapy for Patients With Nonmetastatic Muscle-Invasive Bladder Cancer: Results of the GETUG-AFU V05 VESPER Trial. J Clin Oncol. 2022 Jun 20;40(18):2013-2022. doi: 10.1200/JCO.21.02051. Epub 2022 Mar 7.

Reference Type: BACKGROUND

PMID: 35254888 (View on PubMed)

Witjes JA, Bruins HM, Cathomas R, Comperat EM, Cowan NC, Gakis G, Hernandez V, Linares Espinos E, Lorch A, Neuzillet Y, Rouanne M, Thalmann GN, Veskimae E, Ribal MJ, van der Heijden AG. European Association of Urology Guidelines on Muscle-invasive and Metastatic Bladder Cancer: Summary of the 2020 Guidelines. Eur Urol. 2021 Jan;79(1):82-104. doi: 10.1016/j.eururo.2020.03.055. Epub 2020 Apr 29.

Reference Type: BACKGROUND

PMID: 32360052 (View on PubMed)

Willigenburg T, de Muinck Keizer DM, Peters M, Claes A, Lagendijk JJW, de Boer HCJ, van der Voort van Zyp JRN. Evaluation of daily online contour adaptation by radiation therapists for prostate cancer treatment on an MRI-guided linear accelerator. Clin Transl Radiat Oncol. 2021 Jan 14;27:50-56. doi: 10.1016/j.ctro.2021.01.002. eCollection 2021 Mar.

Reference Type: BACKGROUND

PMID: 33532630 (View on PubMed)

Caffo O, Fellin G, Graffer U, Mussari S, Tomio L, Galligioni E. Gemcitabine and radiotherapy plus cisplatin after transurethral resection as conservative treatment for infiltrating bladder cancer: Long-term cumulative results of 2 prospective single-institution studies. Cancer. 2011 Mar 15;117(6):1190-6. doi: 10.1002/cncr.25667. Epub 2010 Oct 19.

Reference Type: BACKGROUND

PMID: 20960501 (View on PubMed)

Coppin CM, Gospodarowicz MK, James K, Tannock IF, Zee B, Carson J, Pater J, Sullivan LD. Improved local control of invasive bladder cancer by concurrent cisplatin and preoperative or definitive radiation. The National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 1996 Nov;14(11):2901-7. doi: 10.1200/JCO.1996.14.11.2901.

Reference Type: BACKGROUND

PMID: 8918486 (View on PubMed)

Gronborg C, Vestergaard A, Hoyer M, Sohn M, Pedersen EM, Petersen JB, Agerbaek M, Muren LP. Intra-fractional bladder motion and margins in adaptive radiotherapy for urinary bladder cancer. Acta Oncol. 2015;54(9):1461-6. doi: 10.3109/0284186X.2015.1062138. Epub 2015 Aug 27.

Reference Type: BACKGROUND

PMID: 26313410 (View on PubMed)

Giacalone NJ, Shipley WU, Clayman RH, Niemierko A, Drumm M, Heney NM, Michaelson MD, Lee RJ, Saylor PJ, Wszolek MF, Feldman AS, Dahl DM, Zietman AL, Efstathiou JA. Long-term Outcomes After Bladder-preserving Tri-modality Therapy for Patients with Muscle-invasive Bladder Cancer: An Updated Analysis of the Massachusetts General Hospital Experience. Eur Urol. 2017 Jun;71(6):952-960. doi: 10.1016/j.eururo.2016.12.020. Epub 2017 Jan 9.

Reference Type: BACKGROUND

PMID: 28081860 (View on PubMed)

Mak RH, Hunt D, Shipley WU, Efstathiou JA, Tester WJ, Hagan MP, Kaufman DS, Heney NM, Zietman AL. Long-term outcomes in patients with muscle-invasive bladder cancer after selective bladder-preserving combined-modality therapy: a pooled analysis of Radiation Therapy Oncology Group protocols 8802, 8903, 9506, 9706, 9906, and 0233. J Clin Oncol. 2014 Dec 1;32(34):3801-9. doi: 10.1200/JCO.2014.57.5548. Epub 2014 Nov 3.

Reference Type: BACKGROUND

PMID: 25366678 (View on PubMed)

Advanced Bladder Cancer (ABC) Meta-analysis Collaboration. Neoadjuvant chemotherapy in invasive bladder cancer: update of a systematic review and meta-analysis of individual patient data advanced bladder cancer (ABC) meta-analysis collaboration. Eur Urol. 2005 Aug;48(2):202-5; discussion 205-6. doi: 10.1016/j.eururo.2005.04.006. Epub 2005 Apr 21.

Reference Type: BACKGROUND

PMID: 15939524 (View on PubMed)

Shi H, Zhang W, Bi X, Wang D, Xiao Z, Guan Y, Guan K, Tian J, Bai H, Hu L, Cao C, Jiang W, Hu Z, Zhang J, Chen Y, Zheng S, Feng X, Li C, Li Y, Ma J, Liu Y, Zhou A, Shou J. Neoadjuvant Chemotherapy-Guided Bladder-Sparing Treatment for Muscle-Invasive Bladder Cancer: Results of a Pilot Phase II Study. Cancer Res Treat. 2021 Oct;53(4):1156-1165. doi: 10.4143/crt.2020.1356. Epub 2021 Feb 10.

Reference Type: BACKGROUND

PMID: 33592141 (View on PubMed)

Cho SW, Lim SH, Kwon GY, Kim CK, Park W, Pyo H, Chung JH, Song W, Sung HH, Jeong BC, Park SH. Neoadjuvant Cisplatin-Based Chemotherapy Followed by Selective Bladder Preservation Chemoradiotherapy in Muscle-Invasive Urothelial Carcinoma of the Bladder: Post Hoc Analysis of Two Prospective Studies. Cancer Res Treat. 2024 Jul;56(3):893-897. doi: 10.4143/crt.2024.015. Epub 2024 Feb 15.

Reference Type: BACKGROUND

PMID: 38374699 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8558186 (View on PubMed)

Astrom LM, Behrens CP, Calmels L, Sjostrom D, Geertsen P, Mouritsen LS, Serup-Hansen E, Lindberg H, Sibolt P. Online adaptive radiotherapy of urinary bladder cancer with full re-optimization to the anatomy of the day: Initial experience and dosimetric benefits. Radiother Oncol. 2022 Jun;171:37-42. doi: 10.1016/j.radonc.2022.03.014. Epub 2022 Mar 28.

Reference Type: BACKGROUND

PMID: 35358605 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15667962 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14630267 (View on PubMed)

Borut K, Lijana ZK. Phase I study of radiochemotherapy with gemcitabine in invasive bladder cancer. Radiother Oncol. 2012 Mar;102(3):412-5. doi: 10.1016/j.radonc.2011.07.026. Epub 2011 Sep 2.

Reference Type: BACKGROUND

PMID: 21890225 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21205754 (View on PubMed)

Shipley WU, Winter KA, Kaufman DS, Lee WR, Heney NM, Tester WR, Donnelly BJ, Venner PM, Perez CA, Murray KJ, Doggett RS, True LD. Phase III trial of neoadjuvant chemotherapy in patients with invasive bladder cancer treated with selective bladder preservation by combined radiation therapy and chemotherapy: initial results of Radiation Therapy Oncology Group 89-03. J Clin Oncol. 1998 Nov;16(11):3576-83. doi: 10.1200/JCO.1998.16.11.3576.

Reference Type: BACKGROUND

PMID: 9817278 (View on PubMed)

McNair HA, Joyce E, O'Gara G, Jackson M, Peet B, Huddart RA, Wiseman T. Radiographer-led online image guided adaptive radiotherapy: A qualitative investigation of the therapeutic radiographer role. Radiography (Lond). 2021 Nov;27(4):1085-1093. doi: 10.1016/j.radi.2021.04.012. Epub 2021 May 15.

Reference Type: BACKGROUND

PMID: 34006442 (View on PubMed)

James ND, Hussain SA, Hall E, Jenkins P, Tremlett J, Rawlings C, Crundwell M, Sizer B, Sreenivasan T, Hendron C, Lewis R, Waters R, Huddart RA; BC2001 Investigators. Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer. N Engl J Med. 2012 Apr 19;366(16):1477-88. doi: 10.1056/NEJMoa1106106.

Reference Type: BACKGROUND

PMID: 22512481 (View on PubMed)

Huddart RA, Hall E, Hussain SA, Jenkins P, Rawlings C, Tremlett J, Crundwell M, Adab FA, Sheehan D, Syndikus I, Hendron C, Lewis R, Waters R, James ND. Randomized noninferiority trial of reduced high-dose volume versus standard volume radiation therapy for muscle-invasive bladder cancer: results of the BC2001 trial (CRUK/01/004). Int J Radiat Oncol Biol Phys. 2013 Oct 1;87(2):261-9. doi: 10.1016/j.ijrobp.2013.06.2044.

Reference Type: BACKGROUND

PMID: 23958147 (View on PubMed)

Khalifa J, Supiot S, Pignot G, Hennequin C, Blanchard P, Pasquier D, Magne N, de Crevoisier R, Graff-Cailleaud P, Riou O, Cabaille M, Azria D, Latorzeff I, Crehange G, Chapet O, Roupret M, Belhomme S, Mejean A, Culine S, Sargos P. Recommendations for planning and delivery of radical radiotherapy for localized urothelial carcinoma of the bladder. Radiother Oncol. 2021 Aug;161:95-114. doi: 10.1016/j.radonc.2021.06.011. Epub 2021 Jun 10.

Reference Type: BACKGROUND

PMID: 34118357 (View on PubMed)

Amestoy F, Roubaud G, Antoine M, Fonteyne V, Baumann BC, Christodouleas J, Roupret M, Azria D, Zilli T, Hennequin C, Xylinas E, Sargos P; Young Academic Urologists Urothelial Carcinoma Group of the European Association of Urology. Review of hypo-fractionated radiotherapy for localized muscle invasive bladder cancer. Crit Rev Oncol Hematol. 2019 Oct;142:76-85. doi: 10.1016/j.critrevonc.2019.06.010. Epub 2019 Jul 16.

Reference Type: BACKGROUND

PMID: 31377435 (View on PubMed)

Fabiano E, Riou O, Pointreau Y, Perichon N, Durdux C. Role of radiotherapy in the management of bladder cancer: Recommendations of the French society for radiation oncology. Cancer Radiother. 2022 Feb-Apr;26(1-2):315-322. doi: 10.1016/j.canrad.2021.11.006. Epub 2021 Dec 23.

Reference Type: BACKGROUND

PMID: 34955411 (View on PubMed)

Reignier PL, Gauthier H, Hennequin C, Aussedat Q, Xylinas E, Desgrandchamps F, Culine S, Masson-Lecomte A, Dumont C. Survival after sequential neoadjuvant chemotherapy followed by trimodal treatment or radical cystectomy for muscle-invasive bladder cancer. World J Urol. 2023 Nov;41(11):3249-3255. doi: 10.1007/s00345-023-04506-9. Epub 2023 Jul 6.

Reference Type: BACKGROUND

PMID: 37410102 (View on PubMed)

Thompson C, Joseph N, Sanderson B, Logue J, Wylie J, Elliott T, Lyons J, Anandadas C, Choudhury A. Tolerability of Concurrent Chemoradiation Therapy With Gemcitabine (GemX), With and Without Prior Neoadjuvant Chemotherapy, in Muscle Invasive Bladder Cancer. Int J Radiat Oncol Biol Phys. 2017 Mar 15;97(4):732-739. doi: 10.1016/j.ijrobp.2016.11.040. Epub 2016 Nov 27.

Reference Type: BACKGROUND

PMID: 28244408 (View on PubMed)

Related Links

https://www.santepubliquefrance.fr/maladies-et-traumatismes/cancers/cancer-du-sein/documents/rapport-synthese/estimations-nationales-de-l-incidence-et-de-la-mortalite-par-cancer-en-france-metropolitaine-entre-1990-et-2018-volume-1-tumeurs-solides-etud

incidence et de la mortalité par cancer en France métropolitaine

Other Identifiers

PROICM 2024-02 BLA

Identifier Type: -

Identifier Source: org_study_id