Adaptive radiotherapy for bladder cancer: personalizing radiation to shrink margins

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this trial, patients with muscle‑invasive bladder cancer receive either standard radiotherapy or adaptive radiotherapy that adjusts each treatment fraction to the current bladder anatomy. The goal is to maintain tumor control while reducing radiation exposure to surrounding organs like the bowel. The approach uses imaging to capture anatomy before each session and generate a personalized radiation plan. The study compares toxicities and dosimetric quality between the adaptive and standard approaches. Participation is limited to adults with specified staging and prior evaluation requirements within participating French centers.

Why it matters

Who can join: the full rules

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

Where it's running

• Institut du Cancer de Montpellier
  Montpellier, Herault, France Recruiting
• Centre Eugène Marquis
  Rennes, Ille Et Vilaine, France Recruiting
• Centre Oscar Lambret
  Lille, Nord, France Recruiting
• Centre Henri Becquerel
  Rouen, Seine Maritime, France Recruiting
• Institut Sainte Catherine
  Avignon, Var, France Recruiting
• Centre de radiothérapie Saint-Louis
  Toulon, Var, France Recruiting

Study contacts

• Principal investigator: Olivier RIOU, MD — Institut Regional Du Cancer de Montpellier
• Study coordinator: Aurore MOUSSION
• Email: aurore.moussion@icm.unicancer.fr
• Phone: 467613102

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.