Can chemotherapy shrink High-Grade kidney tumors before surgery?
NCT ID NCT01261728
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This trial tests whether giving a combination of two chemotherapy drugs, gemcitabine and cisplatin, before surgery can shrink high-grade tumors in the upper urinary tract, a type of kidney cancer. Participants receive four cycles of the drugs over about 12 weeks, followed by surgery to remove the affected kidney or ureter. The goal is to see if the chemotherapy reduces the tumor stage enough to improve long-term outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gemcitabine and cisplatin
- What this could lead to
- If it works, this could point toward a way to shrink high-grade kidney tumors before surgery, potentially improving outcomes for people with this cancer.
- What could go wrong
- This is a phase II trial with a modest number of participants, so results may not be definitive. Chemotherapy can cause side effects, and not all tumors will respond.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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57 people
The number who actually took part.
- Started
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Dec 2010
- Finished
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Aug 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed high-grade upper tract transitional cell carcinoma at MSKCC or a participating site and/or radiographically visible tumor stage T2-T4a N0/X M0 disease with positive selective urinary cytology or high-grade concomitant bladder tumor. Hydronephrosis associated with tumor on biopsy will be considered invasive by definition. * Medically appropriate candidate for radical nephroureterectomy or ureterectomy as per MSKCC or a participating site attending urologic oncologist * Karnofsky Performance Status ≥ 70% * Age ≥ 18 years of age * Required Initial Laboratory Values: * Absolute neutrophil count ≥ 1500 cells/mm3 * Platelets ≥ 100,000 cells/mm3 * Hemoglobin ≥ 9.0g/dL * Bilirubin ≤ 1.2 * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN for the institution * Alkaline phosphatase ≤ 2.5 x ULN for the institution * Serum creatinine ≤ 1.3 mg/dL if male or ≤ 1.1 mg/dL if female OR calculated creatinine clearance ≥ 55 ml/min/1.73m\^2 If female of childbearing potential, serum pregnancy test is negative. * Patients with reproductive potential must use an effective method to avoid pregnancy for the duration of the trial. ml/min/1.73m2 using the formula: CKD epi : GFR = 141 X min(Scr/κ,1)α X max(Scr/κ,1)-1.209 X 0.993Age X 1.018 \[if female\] X 1.159 \[if black\] * Scr is serum creatinine, k is 0.7 for females and 0.9 for males, a is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1. * If female of childbearing potential, serum pregnancy test is negative. * Patients with reproductive potential must use an effective method to avoid pregnancy for the duration of the trial Exclusion Criteria: * Concomitant bladder urothelial carcinoma is acceptable if it is organ confined and surgically resectable. * Presence of carcinoma in situ (CIS) * Prior systemic chemotherapy (prior intravesical therapy is allowed) * Prior radiation therapy to the bladder * Evidence of NYHA functional class III or IV heart disease. * Serious intercurrent medical or psychiatric illness, including serious active infection. * Preexisting sensory grade 3 neuropathy * Major surgery or radiation therapy \< 4 weeks of starting study treatment. * Concomitant use of any other investigational drugs * Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism. * Ongoing cardiac dysrhythmias of NCI CTCAE Version 4.0 grade ≥ 2. * Uncontrolled hypertension (\>150/100 mmHg despite optimal medical therapy). * Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection. Patients with HIV but no evidence of AIDS will be considered candidates. * Concurrent treatment on another clinical trial involving an intervention which may affect the primary endpoint. Supportive care trials or non-treatment trials, e.g. QOL, are allowed. * Ongoing treatment with therapeutic doses of warfarin or low molecular weight heparin (low dose warfarin up to 2 mg po daily or use of subcutaneous low molecular weight heparin for thromboembolic prophylaxis is allowed). * Pregnancy or breast-feeding. Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the MSKCC and participating site PI. Male patients must be surgically sterile or agree to use effective contraception
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hartford Hospital (Data Collection Only)
Hartford, Connecticut, United States
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Lehigh Valley Health Network (Data Collection Only)
Allentown, Pennsylvania, 18103, United States
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Mayo Clinic - Arizona
Scottsdale, Arizona, 85259, United States
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Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725, United States
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Memorial Sloan Kettering Nassau (Consent and Follow-Up only)
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
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Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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