Locally AdvancedNCT06120387
Combined Postoperative Radiotherapy With Kidney Sparing Surgery for Locally Advanced High-risk Ureteral Cancer
An observational study of Locally Advanced and Urothelial Carcinoma Ureter, run by Xuesong Li at 2 sites in China.
Trial summary
In this study, we propose to conduct an ambispective study to analyze the safety of preserved renal unit surgery combined with postoperative adjuvant radiotherapy in patients with limited stage ureteral cancer with high risk factors, and the efficacy analysis compared with traditional radical surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced, Urothelial Carcinoma Ureter
- What is being tested?
- Radical surgery and Kidney sparing surgery+Postoperative radiotheray
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 2 sitesChina
- Study dates
- 10 Nov 2023to 9 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ureteral cancer patients with high-risk factors (high-risk factors define multifocal; G3; T2-4)
Who may be able to join
- 1) Ureteral cancer patients with high-risk factors (high-risk factors define multifocal; G3; T2-4); surgery may be performed with patients undergoing partial terminal ureteral resection or radical nephroureterectomy 2)Age ≥18 years; 3)Completion of abdominopelvic CT 4 weeks before enrollment to exclude distant metastasis and regional lymph node metastasis.
- 4) Patients did not have other malignant neoplastic diseases in the last 5 years except for non-melanoma of the skin and ductal carcinoma in situ of the breast; Willing to participate in perfecting the necessary examinations and follow-up for the sake of the study, and willing to provide written informed consent.
Who cannot join
- 1) Distant metastasis or retroperitoneal lymph node metastasis (N+) had been detected at the time of surgery; R2 resection patients; history of bladder cancer; 2) History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; 3) Pregnant women or breastfeeding women; or women of childbearing potential who are not practicing reliable contraception; (4) The presence of active infections in those with pre-existing or coexisting bleeding disorders 5) clinically significant cardiac disease (e.g., hypertension controlled with medications, unstable angina, New York Heart Association (NYHA) class ≥II congestive heart failure, unstable symptomatic arrhythmias, or class ≥II peripheral vascular disease); 6) Psychological, family, and social factors leading to lack of informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Departmeng of Urology, Peking University First Hospital
Beijing
Xuesong Li, M.D., +86-15801399116, pineneedle@sina.com
Chunru Xu, M.D., +86-17812172086, xcrbdyy@126.com
- Recruiting
Department of Radiotherapy Oncology, Peking University First Hospital
Beijing
Xianshu Gao, M.D., doctorgaoxs@126.com
Xiaoying Li, M.D., +86-13716109164, 13716109164@139.com
About this study
In this study, we propose to conduct an ambispective study to analyze the safety of preserved renal unit surgery combined with postoperative adjuvant radiotherapy in patients with limited stage ureteral cancer with high risk factors, and the efficacy analysis compared with traditional radical surgery. It is hoped that a treatment method that preserves patients' renal function to improve the tolerance of subsequent drug therapy without decreasing the effect of tumor treatment can be achieved in patients with high-risk factors.
- Conditions
- Locally Advanced, Urothelial Carcinoma Ureter
- Being tested
- Radical surgery, Kidney sparing surgery+Postoperative radiotheray
- Keywords
- upper tract urothelial carcinoma, Radiotherapy, Kidney sparing surgery, Locally advanced, Ambispective cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical surgeryProcedure or surgery
Radical nephroureterectomy
Kidney sparing surgery+Postoperative radiotherayRadiation
Kidney sparing surgery+Postoperative radiotheray
| Study group | Role | What they receive |
|---|---|---|
| Kidney sparing surgery+Postoperative radiotheray cohort | Kidney sparing surgery+Postoperative radiotheray cohort Receives: Radiation: Kidney sparing surgery+Postoperative radiotheray | |
| Radical surgery cohort | Preoperative CT/MRI, chest CT and other examinations are performed to determine the stage of the patient's disease. The surgical plan is the same as the current conventional treatment. After surgery, there is no restriction on the use of postoperative adjuvant chemotherapy or postoperative adjuvant radiotherapy according to the patient's pathological stage and the patient's wish. Receives: Procedure: Radical surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence free survival (LRFS)
Local recurrence
Measured: 1-year, 3-year and 5-year
Renal Function Indicators
eGFR, Crea
Measured: Perioperation and peri-treatment
Secondary outcomes (4)
Metastasis free survival (MFS)
Distant metastasis
Measured: 1-year, 3-year and 5-year
Overall survival (OS)
Overall survival
Measured: 1-year, 3-year and 5-year
Intravesical and contralateral recurrence free survival(IRFS and CRFS)
Intravesical and contralateral recurrence free survival
Measured: 1-year, 3-year and 5-year
Adverse effects (AE)
Adverse effects
Measured: Perioperation and peri-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start10 Nov 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion9 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Locally AdvancedStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuesong Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuesong Li, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120387
- Sponsor's protocol ID
- LUXUS3.0
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Roupret M, Seisen T, Birtle AJ, Capoun O, Comperat EM, Dominguez-Escrig JL, Gurses Andersson I, Liedberg F, Mariappan P, Hugh Mostafid A, Pradere B, van Rhijn BWG, Shariat SF, Rai BP, Soria F, Soukup V, Wood RG, Xylinas EN, Masson-Lecomte A, Gontero P. European Association of Urology Guidelines on Upper Urinary Tract Urothelial Carcinoma: 2023 Update. Eur Urol. 2023 Jul;84(1):49-64. doi: 10.1016/j.eururo.2023.03.013. Epub 2023 Mar 24.
PubMed 36967359Li HZ, Li X, Gao XS, Qi X, Ma MW, Qin S. Oncological Outcomes of Adjuvant Radiotherapy for Partial Ureterectomy in Distal Ureteral Urothelial Carcinoma Patients. Front Oncol. 2021 Sep 30;11:699210. doi: 10.3389/fonc.2021.699210. eCollection 2021.
PubMed 34660268Arcangeli G, Arcangeli S, Strigari L. A systematic review and meta-analysis of clinical trials of bladder-sparing trimodality treatment for muscle-invasive bladder cancer (MIBC). Crit Rev Oncol Hematol. 2015 Apr;94(1):105-15. doi: 10.1016/j.critrevonc.2014.11.007. Epub 2014 Dec 4.
PubMed 25541350
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Postoperative Radiotherapy With Kidney Sparing Surgery for Locally Advanced High-risk Ureteral Cancer
- ClinicalTrials.gov ID
- NCT06120387
- Acronym / sponsor ID
- LUXUS3.0
- Conditions
- Locally Advanced, Urothelial Carcinoma Ureter
- Keywords
- upper tract urothelial carcinoma, Radiotherapy, Kidney sparing surgery, Locally advanced, Ambispective cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Xuesong LiUniversity, hospital or other
- Study start
- 10 Nov 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 9 Nov 2028 (estimated)
- First posted
- 7 Nov 2023 (actual)
- 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.
In this study, we propose to conduct an ambispective study to analyze the safety of preserved renal unit surgery combined with postoperative adjuvant radiotherapy in patients with limited stage ureteral cancer with high risk factors, and the efficacy analysis compared with traditional radical surgery. It is hoped that a treatment method that preserves patients' renal function to improve the tolerance of subsequent drug therapy without decreasing the effect of tumor treatment can be achieved in patients with high-risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kidney sparing surgery+Postoperative radiotheray cohort | – | Radiation: Kidney sparing surgery+Postoperative radiotherayKidney sparing surgery+Postoperative radiotheray cohort |
| Radical surgery cohort | – | Procedure: Radical surgeryPreoperative CT/MRI, chest CT and other examinations are performed to determine the stage of the patient's disease. The surgical plan is the same as the current conventional treatment. After surgery, there is no restriction on the use of postoperative adjuvant chemotherapy or postoperative adjuvant radiotherapy according to the patient's pathological stage and the patient's wish. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ureteral cancer patients with high-risk factors (high-risk factors define multifocal; G3; T2-4)
Key inclusion criteria (2 listed)
- 1) Ureteral cancer patients with high-risk factors (high-risk factors define multifocal; G3; T2-4); surgery may be performed with patients undergoing partial terminal ureteral resection or radical nephroureterectomy 2)Age ≥18 years; 3)Completion of abdominopelvic CT 4 weeks before enrollment to exclude distant metastasis and regional lymph node metastasis.
- 4) Patients did not have other malignant neoplastic diseases in the last 5 years except for non-melanoma of the skin and ductal carcinoma in situ of the breast; Willing to participate in perfecting the necessary examinations and follow-up for the sake of the study, and willing to provide written informed consent.
Key exclusion criteria (1 listed)
- 1) Distant metastasis or retroperitoneal lymph node metastasis (N+) had been detected at the time of surgery; R2 resection patients; history of bladder cancer; 2) History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; 3) Pregnant women or breastfeeding women; or women of childbearing potential who are not practicing reliable contraception; (4) The presence of active infections in those with pre-existing or coexisting bleeding disorders 5) clinically significant cardiac disease (e.g., hypertension controlled with medications, unstable angina, New York Heart Association (NYHA) class ≥II congestive heart failure, unstable symptomatic arrhythmias, or class ≥II peripheral vascular disease); 6) Psychological, family, and social factors leading to lack of informed consent.
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 surgeryRadical nephroureterectomy | Procedure or surgery | Radical surgery cohort |
| Kidney sparing surgery+Postoperative radiotherayKidney sparing surgery+Postoperative radiotheray | Radiation | Kidney sparing surgery+Postoperative radiotheray cohort |
Primary outcome
Local recurrence free survival (LRFS)
Time frame: 1-year, 3-year and 5-year
Local recurrence
Renal Function Indicators
Time frame: Perioperation and peri-treatment
eGFR, Crea
4 secondary outcomes
Metastasis free survival (MFS)
Time frame: 1-year, 3-year and 5-year
Overall survival (OS)
Time frame: 1-year, 3-year and 5-year
Intravesical and contralateral recurrence free survival(IRFS and CRFS)
Time frame: 1-year, 3-year and 5-year
Adverse effects (AE)
Time frame: Perioperation and peri-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 36967359Roupret M, Seisen T, Birtle AJ, Capoun O, Comperat EM, Dominguez-Escrig JL, Gurses Andersson I, Liedberg F, Mariappan P, Hugh Mostafid A, Pradere B, van Rhijn BWG, Shariat SF, Rai BP, Soria F, Soukup V, Wood RG, Xylinas EN, Masson-Lecomte A, Gontero P. European Association of Urology Guidelines on Upper Urinary Tract Urothelial Carcinoma: 2023 Update. Eur Urol. 2023 Jul;84(1):49-64. doi: 10.1016/j.eururo.2023.03.013. Epub 2023 Mar 24.
- Background: PubMed 34660268Li HZ, Li X, Gao XS, Qi X, Ma MW, Qin S. Oncological Outcomes of Adjuvant Radiotherapy for Partial Ureterectomy in Distal Ureteral Urothelial Carcinoma Patients. Front Oncol. 2021 Sep 30;11:699210. doi: 10.3389/fonc.2021.699210. eCollection 2021.
- Background: PubMed 25541350Arcangeli G, Arcangeli S, Strigari L. A systematic review and meta-analysis of clinical trials of bladder-sparing trimodality treatment for muscle-invasive bladder cancer (MIBC). Crit Rev Oncol Hematol. 2015 Apr;94(1):105-15. doi: 10.1016/j.critrevonc.2014.11.007. Epub 2014 Dec 4.
- Individual participant dataSharing planned: Undecided
Related trials for Locally Advanced
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Breast Cancer
RecruitingPhase 2
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
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.
Departmeng of Urology, Peking University First Hospital
Beijing, China
Department of Radiotherapy Oncology, Peking University First Hospital
Beijing, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced and Urothelial Carcinoma Ureter, run by Xuesong Li at 2 sites 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence free survival (LRFS) (time frame: 1-year, 3-year and 5-year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06120387, which also lists 3 linked publications.
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 7 Nov 2023.