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Trial record 37 of 582 for:    Recruiting, Not yet recruiting, Available Studies | Superior

Neoadjuvant Chemotherapy Versus Surgery Alone in Patients With High-Grade UTUC

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ClinicalTrials.gov Identifier: NCT02876861
Recruitment Status : Recruiting
First Posted : August 24, 2016
Last Update Posted : July 8, 2019
Sponsor:
Collaborators:
Central South University
The Third Xiangya Hospital of Central South University
Hunan Cancer Hospital
Hunan Provincial People's Hospital
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Brief Summary:
The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin (GC) for 2-4 cycles can help shrink the tumor before undergoing surgery and improves the overall survival for high-grade upper tract urothelial carcinoma.

Condition or disease Intervention/treatment Phase
High-Grade Upper Tract Urothelial Carcinoma Procedure: Radical nephroureterectomy Procedure: Distal ureterectomy Drug: Neoadjuvant Chemotherapy Phase 2

Detailed Description:
The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin (Gemcitabine, 1250mg/m2, d1 d8, Cisplatin, 75mg/m2, d1-d3, 21d, 2-4 cycles) for 2-4 cycles can help shrink the tumor before undergoing surgery and improves the overall survival for high-grade upper tract urothelial carcinoma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy Versus Surgery Alone in Patients With High-Grade Upper Tract Urothelial Carcinoma
Study Start Date : February 2014
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Surgery alone

Surgeons: the operation shall be performed by senior urologic surgeons. Try to achieve the consistency of operation quality.

Operation: Radical nephroureterectomy (RNU) with an ipsilateral bladder cuff or distal ureterectomy.

Procedure: Radical nephroureterectomy
Radical nephroureterectomy (RNU) with an ipsilateral bladder cuff

Procedure: Distal ureterectomy
Distal ureterectomy.

Experimental: Neoadjuvant chemotherapy and Surgery

Experimental: Neoadjuvant chemotherapy group

Neoadjuvant chemotherapy(Gemcitabine and Cisplatin):

Gemcitabine, 1250mg/m2, d1 d8, Cisplatin, 75mg/m2, d1-d3, 21d, 2-4 cycles.

Surgery:

2-3weeks after Neoadjuvant chemotherapy

Surgeons: the operation shall be performed by senior urologic surgeons. Try to achieve the consistency of operation quality.

Operation: Radical nephroureterectomy (RNU) with an ipsilateral bladder cuff or distal ureterectomy.

Procedure: Radical nephroureterectomy
Radical nephroureterectomy (RNU) with an ipsilateral bladder cuff

Procedure: Distal ureterectomy
Distal ureterectomy.

Drug: Neoadjuvant Chemotherapy
Gemcitabine, 1250mg/m2, d1 d8, Cisplatin, 75mg/m2, d1-d3, 21d, 2-4 cycles.
Other Name: GC




Primary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: 3 years ]
    Disease-free survival


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: after neoadjuvant chemotherapy completion, assessed up to 4 weeks ]
    ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1

  2. Overall survival (OS) [ Time Frame: From date of surgery until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 100 months death from any cause, whichever came first, assessed up to 100 months ]
    Overall survival

  3. Number of participants with chemotherapy-related adverse events as assessed by National Cancer Institute Common Toxicity Criteria version 4.0. [ Time Frame: Through neoadjuvant chemotherapy completion, assessed up to 4 weeks ]
    Number of participants with chemotherapy-related adverse events as assessed by National Cancer Institute Common Toxicity Criteria version 4.0.

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: through study completion, an average of 1 year ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Hydronephrosis associated with tumor on imaging or 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 ≤ 1.5 Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN for the institution Alkaline phosphatase ≤ 2.5 x upper limit of normal (ULN) for the institution Serum creatinine ≤ 1.5 mg/dL and calculated creatinine clearance ≥ 55 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: Chronic kidney disease (CKD) epi : glomerular filtration rate (GFR) = 141 X min(Scr/κ,1)α X max(Scr/κ,1)-1.209 X 0.993 Age 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 New York Heart Association (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876861


Contacts
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Contact: Long Wang, M.D. Ph.D. 008613873151645 doctorwanglong@163.com
Contact: Zhenyu Ou, M.D. Ph.D. 008613739056273 ouzhenyu1@163.com

Locations
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China, Hunan
Xiangya Hospital of Central South Univeristy Recruiting
Changsha, Hunan, China, 410008
Contact: Long Wang, M.D. Ph.D.    008613873151645    doctorwanglong@163.com   
Sponsors and Collaborators
Xiangya Hospital of Central South University
Central South University
The Third Xiangya Hospital of Central South University
Hunan Cancer Hospital
Hunan Provincial People's Hospital
Investigators
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Study Chair: Long Wang, M.D. Ph.D. Xiangya Hospital of Central South University

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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT02876861     History of Changes
Other Study ID Numbers: XYURO001
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Xiangya Hospital of Central South University:
Neoadjuvant chemotherapy
upper tract urothelial carcinoma

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs