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Intervention protocol 07

Adaptive image guided radiotherapy of bladder cancer - a national phase I/II dosse escalation study

Objectives Local control in the bladder is essential for survival of patients with bladder cancer. Improvement in radiation technique resulting in higher local control probability is therefore of outmost importance. The bladder is a highly mobile organ and due to changes in rectal and bladder fillings, there is a risk for geographic miss of the clinical target volume. New strategies such as daily imaging of the bladder tumour with the patient on the treatment couch combined with on board correction of tumour position may be a way to give a focussed high dose boost to the bladder tumour. In the present study, the tumour or the tumour bed after transurethral resection (TURB) is demarcated by means of injection of a radio-oblique substance, Lipoidol into the mucosa of the bladder. Metastasis to the pelvic lymph nodes is an important issue in bladder cancer and elective lymph node irradiation should be considered.
Study outline (intervention) A pilot study evaluating the feasibility of lipoidol marking of the bladder tumour or the tumour bed after TURB is being developed. The feasibility will be followed by a national multicenter Phase I/II dose escalation study focusing on tumour response and toxicity. In this study, a total dose of 68 Gy will be evaluated. Patients treated in the protocol will be followed with toxicity scoring and ano-physiological testing including video-assisted recto-sigmoideoscopy with biopsies and measurements of rectal distensibility.
Expected impact Incorporation of new technologies into radiotherapy of bladder cancer will result in higher tumour dose with reduced dose to the rectum and the bowel, and subsequent improved outcome with higher local control rates and less toxicity.
Linkages with work packages WP 3, 5, 6, 7, 9. From WP03: CBCT coregistration. From WP05. Residual errors in target position after on-line correction. From WP06: Adaptive CBCT based plan. From WP07: Lipoidol marker testing