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About
A prospective, single arm, multicenter, Phase II-Trial to assess safety and efficacy of preoperative Radiation therapy before radical CystEctomy combined with ImmunoTherapy in locally advanced urothelial carcinoma of the bladder
Full description
Patients with locally advanced bladder cancer have a poor prognosis despite radical surgical therapy. The addition of perioperative combination chemotherapy did not add significant benefit to surgery alone. There is data indicating a synergistic effect of radiation and immunotherapy. Therefore, combined application of radiotherapy with Nivolumab before radical cystectomy might lead to improved cure rates and local control in this poor prognosis group with locally advanced bladder cancer. The aim of this phase-II study is to assess feasibility and safety of immunotherapy combined with neoadjuvant radiation before radical cystectomy.
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Inclusion criteria
Histologically confirmed, locally advanced bladder cancer (cT3/4 cN0/N+ cM0)
i. cT3/4 in imaging studies (bladder wall thickening or infiltration of perivesical fat/adjacent organs)
ii. Presence of hydronephrosis (or status post nephrostomy/ureteral stent due to hydronephrosis)
iii. Pelvic lymph nodes ≥ 8 mm in short axis
Ineligibility for neoadjuvant cisplatin-based chemotherapy due to any of the following criteria:
Subjects that are eligible for cisplatin may be candidates if they refuse available neoadjuvant cisplatin-based chemotherapy, despite being informed by the investigator about the treatment options. The subject's refusal must be thoroughly documented.
Eligible for radical cystectomy
ECOG 0 - 2
Estimated life expectancy > 6 months
Adequate function of bone marrow, liver and kidney:
Informed consent:
Body weight 35 kg - 160 kg
Female patients with childbearing potential must have a negative serum pregnancy test prior to start of trial.
Women of childbearing potential (WOCBP) and men (who are sexually active with WOCBP) must use any contraceptive method with a failure rate of less than 1% per year (see Appendix 15.7). These patients will be instructed to adhere to contraception for the period between inclusion into the study and surgery (which leads to sterility). Women who are not of childbearing potential (i.e. who are postmenopausal or surgically sterile) as well as sterile men do not require contraception. If patients do not undergo surgery or in the rare case of fertility preserving cystectomy , effective contraception should be used for at least 5 months following the last dose of Nivolumab. In the latter instance serum pregnancy testing is required in WOCBP at the end of the 5 months.
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33 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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