High-Grade Upper Tract Urothelial CarcinomaPhase 2NCT02876861
Neoadjuvant Chemotherapy Versus Surgery Alone in Patients With High-Grade UTUC
A Phase 2 study testing Radical nephroureterectomy, Distal ureterectomy and Neoadjuvant Chemotherapy in people with High-Grade Upper Tract Urothelial Carcinoma, run by Xiangya Hospital of Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- High-Grade Upper Tract Urothelial Carcinoma
- What is being tested?
- Radical nephroureterectomy, Distal ureterectomy and Neoadjuvant Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangya Hospital of Central South Univeristy
Changsha, Hunan, 410008
About this study
Official title: Neoadjuvant Chemotherapy Versus Surgery Alone in Patients With High-Grade Upper Tract Urothelial Carcinoma
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.
Read the 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.
- Being tested
- Radical nephroureterectomy, Distal ureterectomy, Neoadjuvant Chemotherapy
- Keywords
- Neoadjuvant chemotherapy, upper tract urothelial carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical nephroureterectomyProcedure or surgery
Radical nephroureterectomy (RNU) with an ipsilateral bladder cuff
Distal ureterectomyProcedure or surgery
Distal ureterectomy.
Neoadjuvant ChemotherapyDrug
Also called GC
Gemcitabine, 1250mg/m2, d1 d8, Cisplatin, 75mg/m2, d1-d3, 21d, 2-4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Surgery alone | Active comparator | 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. Receives: Procedure: Radical nephroureterectomy; Procedure: Distal ureterectomy |
| Neoadjuvant chemotherapy and Surgery | Experimental | 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. Receives: Procedure: Radical nephroureterectomy; Procedure: Distal ureterectomy; Drug: Neoadjuvant Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Disease-free survival
Measured: 3 years
Secondary outcomes (4)
Objective Response Rate (ORR)
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
Measured: after neoadjuvant chemotherapy completion, assessed up to 4 weeks
Overall survival (OS)
Overall survival
Measured: 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
Number of participants with chemotherapy-related adverse events as assessed by National Cancer Institute Common Toxicity Criteria version 4.0.
Number of participants with chemotherapy-related adverse events as assessed by National Cancer Institute Common Toxicity Criteria version 4.0.
Measured: Through neoadjuvant chemotherapy completion, assessed up to 4 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startFeb 2014
- Primary completionAug 2022
- Study completionAug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Grade Upper Tract Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Central South University, The Third Xiangya Hospital of Central South University, Hunan Cancer Hospital, Hunan Provincial People's Hospital
- Responsible party
- Sponsor
- Investigators
- Long Wang, M.D. Ph.D., Study chair, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876861
- Sponsor's protocol ID
- XYURO001
- Status last verified
- Jun 2022
- First submitted
- 14 Aug 2016
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy Versus Surgery Alone in Patients With High-Grade Upper Tract Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT02876861
- Acronym / sponsor ID
- XYURO001
- Keywords
- Neoadjuvant chemotherapy, upper tract urothelial carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Central South University, The Third Xiangya Hospital of Central South University, Hunan Cancer Hospital, Hunan Provincial People's Hospital
- Study start
- Feb 2014
- Primary completion
- Aug 2022 (actual)
- Study completion
- Aug 2022 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery alone | Active comparator | Procedure: Radical nephroureterectomy, Procedure: Distal ureterectomySurgeons: 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. |
| Neoadjuvant chemotherapy and Surgery | Experimental | Procedure: Radical nephroureterectomy, Procedure: Distal ureterectomy, Drug: Neoadjuvant ChemotherapyExperimental: 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical nephroureterectomyRadical nephroureterectomy (RNU) with an ipsilateral bladder cuff | Procedure or surgery | Neoadjuvant chemotherapy and Surgery, Surgery alone |
| Distal ureterectomyDistal ureterectomy. | Procedure or surgery | Neoadjuvant chemotherapy and Surgery, Surgery alone |
| Neoadjuvant ChemotherapyAlso: GCGemcitabine, 1250mg/m2, d1 d8, Cisplatin, 75mg/m2, d1-d3, 21d, 2-4 cycles. | Drug | Neoadjuvant chemotherapy and Surgery |
Primary outcome
Disease-free survival (DFS)
Time frame: 3 years
Disease-free survival
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: after neoadjuvant chemotherapy completion, assessed up to 4 weeks
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
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 treatment-related adverse events as assessed by CTCAE v4.0
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Long Wang, M.D. Ph.D. study chair
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radical nephroureterectomy, Distal ureterectomy and Neoadjuvant Chemotherapy in people with High-Grade Upper Tract Urothelial Carcinoma, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.