KCT0008059
Not yet recruiting
未知
A Phase 2 tRial of nEoadjuvant Chemotherapy in patiEnts with raDically reEectable upper tract urothelial carcinoma (PRECEDE trial)A randomized Phase 2 tRial of nEoadjuvant Chemotherapy vErsus aDjuvant chEmotherapy in patients with radically resectable upper tract urothelial carcinoma (PRECEDE trial)
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Asan Medical Center
- Enrollment
- 30
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Histologically confirmed high grade urothelial carcinoma of ureter or renal pelvis. Cytologically confirmed urothelial cancer with radiologically visible mass in ureter or renal pelvis can be eligible, too.
- •?Pathologically confirmed high grade urothelial cancer
- •?Positive high grade urothelial cancer in urine cytology according to Paris system with visualized mass on radiologic examination (CT and/or MR)
- •?Positive high grade urothelial cancer in urine cytology according to Paris system with visualized mass on ureteroscope
- •2\)Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
- •3\)Age 19 years or older but 80 years or less
- •4\)Patients with curatively resectable localized or locally advanced upper tract urothelial cancer (cT2\-4N0M0 or cT2\-4NxM0\). Resectability should be confirmed in multidisciplinary meeting which includes medical oncologist, urologist, and radiation oncologist.
- •5\)Creatinine clearance \= 50 mL/min either by Cockcroft\-Gault or 24 hour urine collection at the time of screening
- •6\)ECOG performance status 0 or 1
- •7\)Adequate organ function
Exclusion Criteria
- •1\)pure non\-urothelial histology. However, mixed histology with urothelial and non\-urothelial can be enrolled if urothelial cancer is predominant (\=50%).
- •2\)Presence of metastasis or unresectable localized disease
- •3\)Previous systemic treatment, radiotherapy, or radical surgery for upper tract urothelial cancer.
- •4\)Grade 2 or more peripheral neuropathy by NCI CTCAE
- •5\)Clinically significant medical or psychiatric disease or condition including but not limited to the following conditions;
- •? Unstable angina pectoris, congestive heart failure greater than New York Heart Association (NYHA) Class IV, myocardial infarction within 6 months of the screening, uncontrolled clinically significant cardiac arrhythmia.
- •?Active and/or uncontrolled severe infection
- •?Liver cirrhosis and/or chronic active hepatitis causing liver dysfunction
- •?Pulmonary disease causing serious lung function impairment (resting arterial oxygen saturation\=90%, vital capacity or diffusion capacity\=50% of normal value)
- •?Clinically significant hemoptysis or gastrointestinal bleeding
Outcomes
Primary Outcomes
Not specified
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