Phase II Clinical Trial Of Neoadjuvant Chemotherapy (NAC)In Upper Tract Urothelial Carcinoma (UTUC)

Date de début de l'étude : 1 septembre 2012

Inclusion Criteria: Patients must have HIGH GRADE upper tract urothelial carcinoma Patients must be considered to be a candidate for surgery with curative intent (nephroureterectomy or distal ureterectomy) with lymph node dissection by the treating urologist at baseline within 42 days prior to registration. Patients must be able to care for themselves and must be up and about more than 50% of waking hours All patients must be evaluated by a medical oncologist at baseline within 42 days prior to registration. Patients must be considered to be a candidate for cisplatin-based neoadjuvant chemotherapy by a medical oncologist at baseline and must have adequate kidney function and any pre-existing peripheral neuropathy must be moderate to mild. Prior uro-oncologic history: History of or active non-invasive carcinoma or carcinoma in situ of the bladder or upper tract is allowed. Patients may have received prior intravesical chemotherapy or immunotherapy such as BCG. Prior neoadjuvant chemotherapy for bladder cancer or invasive contralateral upper tract cancer is allowed. Prior adjuvant chemotherapy for bladder cancer or invasive contralateral upper tract cancer is allowed but must have been completed ≥2 years prior to study registration. Patients must have adequate organ and bone marrow function as determined by screening tests Patients must have recovered from any reversible toxicities of prior procedure or surgery Patients must be 18 years or older on date of registration All patients must be informed of the investigational nature of this study and must sign an informed consent document Exclusion Criteria: Patients must have no evidence of regional lymphadenopathy or distant metastasis on imaging. No history of invasive or node positive or metastatic bladder cancer or invasive contralateral upper tract cancer within 2 years prior to registration. Patients with one kidney are not eligible Patients may not be enrolled in another interventional clinical trial at the time of registration. No prior non-urothelial malignancy is allowed, except for cancer from which the patient has been disease free for at least 1 year at the discretion of the treating oncologist. History of adequately treated (at the discretion of the treating oncologist) basal cell or squamous cell skin cancer or in situ cervical cancers is allowed. Pregnant or lactating women are not eligible. Women/men of reproductive potential must agree to use an effective contraceptive method. Women with reproductive potential must have a negative pregnancy test within 14 days prior to registration. Patients must not have any other medical condition(s) that make(s) their participation in the study unadvisable in the opinion of the treating oncologist.