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NCT07043543

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

Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

View on ClinicalTrials.gov

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.

Official title: Randomized Open Phase II Multienter Study Evaluating the Clinical Utility of Online Adaptive Radiotherapy in Bladder Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-01-15

Completion Date

2033-09-30

Last Updated

2025-12-15

Healthy Volunteers

Conditions

Bladder Cancer

Interventions

RADIATION

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)

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)

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

Locations (11)

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