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

Korábbi kezelés

• Prior pelvic radiation therapy;

Más betegség

• 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;
• Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease);
• Uncontrolled immune or cardiac or pulmonary disease;

Egyéb

• Presence of endopenic stent;
• Inability to comply with the protocol;
• Grade 1 or greater baseline diarrhea;
• 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

• 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