Full title: Identification of muscle-invasive bladder cancer patients who will not benefit from neoadjuvant chemotherapy using circulating tumor cells
This prospective, open study has the objective to prospectively assess whether the presence of CTC’s in the peripheral blood of non-metastatic MIBC patients can identify patients with such a good prognosis not justifying neoadjuvant chemotherapy. Secondary study objectives include the association of CTC-positivity or negativity with cancer-specific survival, relapse-free survival, local relapse-free survival and metastasis-free survival, as well as assessing the prognostic value of a 20-gene expression profile in non-metastatic MIBC patients and its added value to a CTC count.
Study population: Patients with stage T2-T4aNO-1MO urothelial carcinoma of the bladder who are candidate for radical local treatment (radical cystectomy).
Intervention: In all patients, CTC’s will be enumerated. If no CTC’s are detected, the patient will proceed to undergo local radical treatment (radical cystectomy) and will not receive neoadjuvant chemotherapy. In the case CTC’s are detected, patients may undergo neoadjuvant chemotherapy followed by radical local treatment, dependent on the local guidelines.
Main study parameters/endpoints: To prospectively assess whether the absence of CTC’s in the peripheral blood of non-metastatic MIBC patients can identify patients with such favorable prognosis that they are not benefitting from neoadjuvant chemotherapy.
Principal investigator in Erasmus MC: J.L. Boormans, MD PhD (Dept. of Urology), Prof. S. Sleijfer, MD PhD (Dept. Of Medical Oncology)
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Klik hier voor update CirGuidance, DUOS Symposium, 4 december 2015