Phase 2 Bladder Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You must be 18 years of age or older
• You must be well enough to carry out basic daily activities with only minor limitations (your doctor can assess this using a standard scale)
• You must have bladder cancer of a specific type called urothelial cancer, confirmed by a tissue test — both pure forms and mixed types are allowed
• Your cancer must have spread to nearby lymph nodes and/or other parts of the body, confirmed by a detailed scan, either as a new diagnosis or as a first return of the cancer after bladder removal surgery (but not as a return at the surgery site itself)
• You must have already completed 4 to 6 cycles of first-line treatment for metastatic cancer (chemotherapy and/or immunotherapy), or have already started a maintenance therapy phase
• Your cancer must not have grown or spread during that first-line treatment
• You must have no more than 3 remaining cancer spots in distant parts of the body after your first-line treatment — nearby lymph nodes in the pelvis are not counted in this number (confirm with trial site for full details on how lesions are counted)
• Any remaining cancer spots must be suitable for a targeted radiation treatment called SBRT, with no previous radiotherapy in those areas that would interfere
• You must be randomised into the trial within 8 weeks of finishing the main phase of your systemic treatment
• You must have no medical reasons preventing you from receiving pelvic radiotherapy
• You must be willing and able to give written consent and follow the study procedures
• You must be covered by a Social Health Insurance scheme in France

Who may not be able to join:

• Your bladder cancer is not urothelial type — for example, if it is squamous cell, adenocarcinoma, or neuroendocrine type
• You had cancer that had spread to the brain before starting systemic treatment
• You had cancer that had spread to the liver before starting systemic treatment
• There is nothing left to treat with radiation — for example, if you had your bladder removed, have no remaining distant cancer spots, and had no lymph node involvement at diagnosis
• Your cancer came back after you previously received combined chemotherapy and radiotherapy to treat the bladder
• Your cancer has come back at the site where your bladder was removed
• You have already had radiotherapy to the pelvic area
• You have had radiotherapy near the remaining cancer spots that would make the targeted SBRT radiation unsafe
• You have an active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)
• You have an organ condition that makes SBRT unsafe — for example, if you have a lung lesion along with a known or suspected lung scarring condition (confirm with trial site)
• You have a history of scleroderma (a connective tissue disease)
• You have been diagnosed with another cancer in the last 5 years — with limited exceptions for certain low-risk skin or prostate cancers found incidentally (confirm with trial site for exact details)
• You are pregnant, breastfeeding, or not using adequate contraception
• You have a known psychiatric condition or substance use problem that could affect your ability to take part
• Any personal, family, geographic, or social situation that your doctor feels could prevent you from properly consenting or following the study
• Your freedom is restricted by law, or you are under a legal protection order
• You are currently taking part in another interventional clinical trial

Important: Always verify eligibility with the trial site directly before applying.