Renal Pelvis CancerNCT06652009
Radical Radiotherapy Versus Radical Surgery for UTUC
An observational study of Renal Pelvis Cancer, run by Peking University First Hospital at 2 sites in China.
Trial summary
This study is a prospective cohort study, and the proposed plan is to recruit 30 patients with radical radiotherapy for renal pelvic ureteral cancer, according to the actual clinical situation, enrolling the same period of time to choose the operation of the elderly, combined with the risk of anaesthesia or regional… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Pelvis Cancer
- What is being tested?
- Radical nephroureterectomy and Radical radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2022to 30 Dec 2029
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ureteral cancer of the renal pelvis in patients with advanced age, combined anaesthetic risk or regional lymph node metastases
Who may be able to join
- Uroepithelial carcinoma of the renal pelvis or ureter supported by clinical symptoms, imaging, histopathology, urocytology, or fluorescence in situ hybridisation (FISH), or those who satisfy FISH positivity despite the absence of pathology or the patient's refusal to be punctured and who are judged to have a renal pelvic or ureteral carcinoma by an imaging physician and a urologist on the basis of CTU or MRU or PETCT; No distant metastases were detected on full screening; Patients who are unable to undergo surgical treatment due to poor general condition, inability to be anaesthetised or to tolerate surgery, or refusal to undergo surgery; patients who are over 70 years old; or patients who are less than 70 years old combined with underlying diseases or the presence of regional lymph node metastasis, etc. who are otherwise unable to undergo radical surgery; Expected survival ≥ 6 months; Willingness and ability to comply with trial and follow-up procedural arrangements; voluntarily agree to participate in the study and sign an informed consent form.
Who cannot join
- Previous abdominopelvic radiotherapy; Other serious, uncontrolled concomitant disease that may affect adherence to the protocol or interfere with interpretation of results; Other malignancies within 5 years prior to the start of study dosing, with the exception of malignancies that can be expected to resolve with treatment (including, but not limited to, adequately treated thyroid cancer, cervical cancer in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated by radical surgery); estimated that patients' adherence to participation in this clinical study was insufficient.
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., +86-13716109164, doctorgaoxs@126.com
Xiaoying Li, M.D., +86-13716109164, 13716109164@139.com
About this study
Official title: Efficacy of Radical Radiotherapy Compared with Surgical Treatment in Patients with Upper Tract Urothelial Carcinoma: a Prospective Cohort Study
This study is a prospective cohort study, and the proposed plan is to recruit 30 patients with radical radiotherapy for renal pelvic ureteral cancer, according to the actual clinical situation, enrolling the same period of time to choose the operation of the elderly, combined with the risk of anaesthesia or regional lymph node metastasis of the patients, initially tentatively set at 60. The patients were divided into the surgery group and radiotherapy group according to the actual choice of treatment. In the control group, standard nephroureterectomy was used, and in the experimental group, stereotactic body radiation therapy (SBRT) or moderately segmented radical radiotherapy was used.
Read the detailed description
- No lymph node metastasis Choose SBRT radiotherapy as much as possible Tumour PTV 50Gy/10f; if the tumour is close to the intestine, the radiotherapy dose can be appropriately reduced 40-50Gy/8-10f; to ensure intestinal safety 2）With regional lymph node metastasis Renal pelvis tumour: tumour PGTV 62.5Gy/25f; for tumour larger than 3cm P-SBRT radiotherapy is feasible, SBRT 18-24Gy/3-4f; Affected kidney + para-abdominal aorta + common iliac lymph node drainage area 47.5Gy/25f; metastatic lymph nodes 62.5Gy/25f.
- Routinely segmented normal tissue limits are as follows: Contralateral kidney V20<15% Dmean 15Gy Duodenum Dmax<50Gy Jejunum/ileum/colon V50<5% Dmax<52Gy Spinal cord Damx <40Gy Liver At least 700cc volume should receive a dose <25Gy
SBRT segmentation Normal tissue limits are as follows:
Duodenum Dmax<32Gy; V18<5cc Jejunum/ileum/colon Dmax<35Gy; V19.5<5cc Stomach Dmax<32Gy; V18<5cc (4) Short-term efficacy judgement: 1 month after radiotherapy to review imaging, short-term efficacy based on RECIST1.1 criteria, partial remission (PR partial regression) or complete remission (CR complete regression); disease-free survival is defined as the period after treatment to the emergence of recurrence in the radiotherapy field, intra-urethral recurrence (except bladder recurrence) or Regional lymph node metastases at first recurrence.
- Conditions
- Renal Pelvis Cancer
- Being tested
- Radical nephroureterectomy, Radical radiotherapy
- Keywords
- Renal pelvis carcinoma, Radical radiotherapy, Radical surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical nephroureterectomyOther
Radical nephroureterectomy
Radical radiotherapyRadiation
Radical radiotherapy with stereotactic body radiation therapy (SBRT) or moderately segmented radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Radical surgery group | Patients undergo radical nephroureterectomy Receives: Other: Radical nephroureterectomy | |
| Radical radiotherapy cohort | Patients undergo radical radiotherapy with stereotactic body radiation therapy (SBRT) or moderately segmented radiotherapy Receives: Radiation: Radical radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative changes in renal function(eGFR)
Postoperative changes in renal function(eGFR)
Measured: Immediately postoperatively, 1 month and 6-12 months postoperatively
Secondary outcomes (4)
Adverse effects
Adverse effects related to radiotherapy and surgery
Measured: 1 month after the start of treatment until the end of treatment
OS
Overall survival
Measured: Until the end of the project, an average of 5 years; a mid-term analysis is usually implemented at the 3rd year.
PFS
Progression-free survival
Measured: Until the end of the project, an average of 5 years; a mid-term analysis is usually implemented at the 3rd year.
Local response rate(LRR)
Local response rate(LRR)
Measured: 1 month and 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Pelvis CancerStudies 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI xiaoying, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652009
- Sponsor's protocol ID
- LUXUS6.0
- Status last verified
- Oct 2024
- First submitted
- 12 Sep 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Radical Radiotherapy Compared with Surgical Treatment in Patients with Upper Tract Urothelial Carcinoma: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06652009
- Acronym / sponsor ID
- LUXUS6.0
- Conditions
- Renal Pelvis Cancer
- Keywords
- Renal pelvis carcinoma, Radical radiotherapy, Radical surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 22 Oct 2024 (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.
This study is a prospective cohort study, and the proposed plan is to recruit 30 patients with radical radiotherapy for renal pelvic ureteral cancer, according to the actual clinical situation, enrolling the same period of time to choose the operation of the elderly, combined with the risk of anaesthesia or regional lymph node metastasis of the patients, initially tentatively set at 60. The patients were divided into the surgery group and radiotherapy group according to the actual choice of treatment. In the control group, standard nephroureterectomy was used, and in the experimental group, stereotactic body radiation therapy (SBRT) or moderately segmented radical radiotherapy was used.
Detailed description
- No lymph node metastasis Choose SBRT radiotherapy as much as possible Tumour PTV 50Gy/10f; if the tumour is close to the intestine, the radiotherapy dose can be appropriately reduced 40-50Gy/8-10f; to ensure intestinal safety 2）With regional lymph node metastasis Renal pelvis tumour: tumour PGTV 62.5Gy/25f; for tumour larger than 3cm P-SBRT radiotherapy is feasible, SBRT 18-24Gy/3-4f; Affected kidney + para-abdominal aorta + common iliac lymph node drainage area 47.5Gy/25f; metastatic lymph nodes 62.5Gy/25f.
- Routinely segmented normal tissue limits are as follows: Contralateral kidney V20<15% Dmean 15Gy Duodenum Dmax<50Gy Jejunum/ileum/colon V50<5% Dmax<52Gy Spinal cord Damx <40Gy Liver At least 700cc volume should receive a dose <25Gy
SBRT segmentation Normal tissue limits are as follows:
Duodenum Dmax<32Gy; V18<5cc Jejunum/ileum/colon Dmax<35Gy; V19.5<5cc Stomach Dmax<32Gy; V18<5cc (4) Short-term efficacy judgement: 1 month after radiotherapy to review imaging, short-term efficacy based on RECIST1.1 criteria, partial remission (PR partial regression) or complete remission (CR complete regression); disease-free survival is defined as the period after treatment to the emergence of recurrence in the radiotherapy field, intra-urethral recurrence (except bladder recurrence) or Regional lymph node metastases at first recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radical surgery group | – | Other: Radical nephroureterectomyPatients undergo radical nephroureterectomy |
| Radical radiotherapy cohort | – | Radiation: Radical radiotherapyPatients undergo radical radiotherapy with stereotactic body radiation therapy (SBRT) or moderately segmented radiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ureteral cancer of the renal pelvis in patients with advanced age, combined anaesthetic risk or regional lymph node metastases
Key inclusion criteria (1 listed)
- Uroepithelial carcinoma of the renal pelvis or ureter supported by clinical symptoms, imaging, histopathology, urocytology, or fluorescence in situ hybridisation (FISH), or those who satisfy FISH positivity despite the absence of pathology or the patient's refusal to be punctured and who are judged to have a renal pelvic or ureteral carcinoma by an imaging physician and a urologist on the basis of CTU or MRU or PETCT; No distant metastases were detected on full screening; Patients who are unable to undergo surgical treatment due to poor general condition, inability to be anaesthetised or to tolerate surgery, or refusal to undergo surgery; patients who are over 70 years old; or patients who are less than 70 years old combined with underlying diseases or the presence of regional lymph node metastasis, etc. who are otherwise unable to undergo radical surgery; Expected survival ≥ 6 months; Willingness and ability to comply with trial and follow-up procedural arrangements; voluntarily agree to participate in the study and sign an informed consent form.
Key exclusion criteria (1 listed)
- Previous abdominopelvic radiotherapy; Other serious, uncontrolled concomitant disease that may affect adherence to the protocol or interfere with interpretation of results; Other malignancies within 5 years prior to the start of study dosing, with the exception of malignancies that can be expected to resolve with treatment (including, but not limited to, adequately treated thyroid cancer, cervical cancer in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated by radical surgery); estimated that patients' adherence to participation in this clinical study was insufficient.
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 | Other | Radical surgery group |
| Radical radiotherapyRadical radiotherapy with stereotactic body radiation therapy (SBRT) or moderately segmented radiotherapy | Radiation | Radical radiotherapy cohort |
Primary outcome
Postoperative changes in renal function(eGFR)
Time frame: Immediately postoperatively, 1 month and 6-12 months postoperatively
Postoperative changes in renal function(eGFR)
4 secondary outcomes
Adverse effects
Time frame: 1 month after the start of treatment until the end of treatment
OS
Time frame: Until the end of the project, an average of 5 years; a mid-term analysis is usually implemented at the 3rd year.
PFS
Time frame: Until the end of the project, an average of 5 years; a mid-term analysis is usually implemented at the 3rd year.
Local response rate(LRR)
Time frame: 1 month and 1 year after 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 22 Oct 2024.
- Individual participant dataSharing planned: Yes
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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.
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 Renal Pelvis Cancer, run by Peking University First Hospital 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 1 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 22 Oct 2024. 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?
Postoperative changes in renal function(eGFR) (time frame: Immediately postoperatively, 1 month and 6-12 months postoperatively). 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 22 Oct 2024.