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)
- Conditions
- Neoplasms
- Registration Number
- KCT0008059
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 30
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
?Bone marrow function
- Neutrophil ? 1,500/mm3
- Platelet ? 100,000/mm3
- Hemoglobin ? 9 g/dL
?Liver function
- Total bilirubin =1.5xULN (in case of Gilbert syndrome, =2.5xULN)
- AST, ALT =3xULN
?cardiac function
- left ventricular ejection fraction=50% by cardiac echocardiography or MUGA scan
- Asymptomatic patients will not need cardiac function test
8)female of childbearing potential who are negative in a pregnancy test within 14 days before enrollment. Both male and female patients should agree to use an adequate method of contraception during the study therapy through 120 days after the last dose of study therapy. Effective contraception methods include transplantation of a single progestogen ingredient, the use of hormonal contraceptives by female participants, must use male condoms, and sexual abstinence.
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
?Psychiatric disease which can preclude the patients from undergoing appropriate clinical trial procedures, and mood disorder or psychiatric illness which are inappropriate for participating clinical trial by investigator’s perspective
6)Presence of 2nd primary neoplasm at the time of screening procedure. But endoscopically manageable lower urinary tract cancer (bladder cancer or urethral cancer) with only non-muscle invasive pathology can be enrolled
7)Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri or prostate cancer and curatively treated thyroid cancer of any stage.
8)Pregnancy or breast feeding
9)All medical contraindications for platinum (cisplatin)-based double chemotherapy treatment, including:
–CTCAE Grade 2 or higher hearing loss
–CTCAE Grade II or higher peripheral neuropathy
–If you have a history of overreaction to mannitol, a drug containing platinum,
– Patients with severe liver failure/severe bone marrow dysfunction/acute infection
– Patients with hemorrhagic tumors
- If you have epileptic pneumonia or pulmonary fibrosis with clinical symptoms evident from a simple x-ray of the chest
- If radiation therapy is performed on the chest
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method proportion of <ypT2 rate
- Secondary Outcome Measures
Name Time Method Disease Free Survival (DFS), ;Overall survival (OS), ;safety profile