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.
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
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;
Parallel
Adaptive radiotherapy
RadiationPatient 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 radiotherapy
RadiationPatient 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)
evaluation of the technique of adaptive radiotherapy in terms of acute Gastro-Intestinal toxicity.
rate of patients without acute diarrhea grade ≥2
Evaluation of all acute toxicities
description of all acute toxicities according to Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0)
Evaluation of all late toxicities
description of all late toxicities according to Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0)
evaluation of quality of life specific to the cancer disease
Quality of life will be evaluated using European Organisation for Research and Treatment of Cancer - Quality Life Questionnaire (EORTC QLQ-C30)
evaluation of quality of life and of the measurements specific to the treatment of bladder cancer with muscle invasion
Quality of life will be evaluated using European Organisation for Research and Treatment of Cancer - Quality Life Questionnaire - Bladder Cancer (EORTC QLQ-BLM30)
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Institut du Cancer de Montpellier - Val d'Aurelle
Lead sponsor
Ligue contre le cancer, France
Collaborator
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