Urothelial Carcinoma of the Renal Pelvis and UreterLUXUS07NCT06472752
Neoadjuvant Radiotherapy for High-risk UTUC
An observational study of Urothelial Carcinoma of the Renal Pelvis and Ureter, run by Peking University First Hospital at 1 site in China.
Trial summary
The investigators propose to conduct an open-label, single-arm, prospective cohort study to collect and observe high-risk UTUC patients (with clear pathology of urothelial carcinoma and at least one of the following (muscle invasion [cT2 and above], high-grade tumour, multifocality, tumour diameter of ≥2cm, with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma of the Renal Pelvis and Ureter
- What is being tested?
- Neoadjuvant radiotherapy and Neoadjuvant drug therapy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2024to 30 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is an open-label, single-arm, prospective cohort study, and the eligibility criteria for subjects to be included in the study are the same as the inclusion criteria. They will be informed of their informed consent and will voluntarily enrol in the study and sign an informed consent form prior to receiving their first treatment.
Who may be able to join
- ·≥18 years old, no gender limits, diagnosed as high-risk UTUC without existing distant metastasis or other malignancies;
- Completed pathological biopsy with a clear pathological diagnosis : including puncture biopsy, ureteroscopy and urine cytology, at least one of which is clearly diagnosed as uroepithelial carcinoma, which may include no more than 50% or more proportion of squamous, adenoid, sarcomatoid differentiation and other special differentiation types;
- Have the willingness to undergo radical surgical treatment and perioperative adjuvant treatment, have good compliance, and be able to co-operate with the treatment and follow-up plan specified by the clinician;
- Postoperative life expectancy of at least 6 months; ECOG score ≤ 2.
Who cannot join
- Distant metastases or other malignant neoplastic diseases combined with other malignant neoplasms in the same period had been detected at the time of surgery, or the present was a progression after palliative resection of previous epithelial carcinoma of the urothelium;
- History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy;
- Pregnant women or breastfeeding women; or women of childbearing potential who are not using reliable contraception;
- The presence of active infections in those with pre-existing or coexisting haemorrhagic disorders
- 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);
- Psychological, familial, and social factors leading to lack of informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Neoadjuvant Radiotherapy for High-risk Upper Tract Urothelial Carcinoma: A Single-arm, Open Label, Prospective Cohort Study
The investigators propose to conduct an open-label, single-arm, prospective cohort study to collect and observe high-risk UTUC patients (with clear pathology of urothelial carcinoma and at least one of the following (muscle invasion [cT2 and above], high-grade tumour, multifocality, tumour diameter of ≥2cm, with hydronephrosis or regional lymph node metastasis) who undergo neoadjuvant therapy(neoadjuvant radiotherapy with/without drug) + radical nephroureterectomy. The cohort was evaluated by regular follow-up for safety and prognosis during the real-world neoadjuvant treatment period, perioperative period, and long-term postoperative follow-up.
Read the detailed description
The investigators propose to conduct an open-label, single-arm, prospective cohort study to collect and observe high-risk UTUC patients (with clear pathology of urothelial carcinoma and at least one of the following (muscle invasion [cT2 and above], high-grade tumour, multifocality, tumour diameter of ≥2cm, with hydronephrosis or regional lymph node metastasis) who undergo neoadjuvant therapy(neoadjuvant radiotherapy with/without drug like chemotherapy, immunotherapy or ADC and etc.) + radical nephroureterectomy. The cohort was evaluated by regular follow-up for safety and prognosis during the real-world neoadjuvant treatment period, perioperative period, and long-term postoperative follow-up.
Two cohorts will be enrolled in the project: Cohort 1: high-risk UTUC patients without distant metastases (may be accompanied by regional lymph node metastases) will receive a short course of neoadjuvant stereotactic radiotherapy (neoadjuvant SBRT) after completing a biopsy with a clear pathological diagnosis, and then undergo a radical surgery within 3 months after the completion of the last radiotherapy; Cohort 2: high-risk UTUC patients without distant metastases (may be accompanied by regional lymph node metastases) will receive short course neoadjuvant SBRT after completing a biopsy and making a clear pathological diagnosis. distant metastases (may be accompanied by regional lymph node metastases) of high-risk UTUC patients, who received short-course neoadjuvant stereotactic radiotherapy (neoadjuvant SBRT, naSBRT) + drug therapy after completing biopsy and clear pathological diagnosis, and were treated with radical surgical therapy (full-length radical nephroureterectomy + cystocele sleeve resection) within 3 months from the completion of the last radiotherapy treatment . Drug treatment could be chemotherapy/immunotherapy/ADC treatment etc.
Patients in both cohorts were evaluated by physicians after radical surgery for the need of additional adjuvant therapies (including but not limited to chemotherapy/immunotherapy/targeted or other molecular therapies, etc.) for 3 months after surgery based on pathological diagnosis, during which time the patients' adverse reactions and quality of life scores were closely monitored and recorded.
Postoperatively, each enrolled patient received regular review (including but not limited to CT, MRI, ultrasound, blood and urine routine, cystoscopy) every 3 months for 2 years after surgery and every 6 months for 3-5 years after surgery, as recommended by current guidelines. When target events including death, local recurrence (including retroperitoneal lymph node metastasis, recurrence in the tumour bed in the operation field, etc.), distant metastasis, bladder recurrence, etc. were observed then the time of the first observation and the corresponding type of event were recorded in detail, and the time interval from the start of the first neoadjuvant radiotherapy was calculated. At the same time, blood routine, lymphocyte typing information, blood and urine specimens, pre-operative biopsies and post-radical surgery pathology specimens were collected during the treatment period for the exploratory study of the corresponding molecular markers to evaluate the characteristics of patients' organism and the tumour immune microenvironment.
- Being tested
- Neoadjuvant radiotherapy, Neoadjuvant drug therapy
- Keywords
- neoadjuvant radiotherapy, UTUC, prospective cohort, microenviroment, neoadjuvant combined therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant radiotherapyRadiation
Patients with a clear pathological diagnosis of high-risk UTUC were treated with a short course of 5 days of naSBRT: radiotherapy irradiation was directed to the primary lesion on the affected side and to the lymphatic drainage area, with a dose of 25 Gy (5 Gy*5 days).The safety of the neoadjuvant radiotherapy dose and regimen can be evaluated by metrological ramping in the initial 5 patients, with subsequent patients following the optimal dose from ramping.
Neoadjuvant drug therapyCombination product
Patients will concurrently complete at least 2-4 cycles of preoperative neoadjuvant chemotherapy/immunotherapy/ADCs as well.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant radiotherapy+radical surgery | Patients with high-risk UTUC without distant metastases (which can be accompanied by regional lymph node metastases) were selected to receive short-course neoadjuvant stereotactic radiotherapy (neoadjuvant SBRT, naSBRT) after completion of biopsy and definitive pathological diagnosis, and to undergo radical surgery within 3 months from completion of the last radiotherapy session Receives: Radiation: Neoadjuvant radiotherapy | |
| Neoadjuvant radiotherapy and drug therapy+radical surgery | Patients with high-risk UTUC without distant metastases (which may be accompanied by regional lymph node metastases) were selected to receive a short course of neoadjuvant stereotactic radiotherapy (neoadjuvant SBRT, naSBRT) + drug therapy after completing a biopsy and making a definitive pathological diagnosis, and to undergo a radical surgical procedure within 3 months from the end of the last radiotherapy session (full-length radical nephroureteral resection + cystocele sleeve resection ) treatment. Pharmacological treatment can be chemotherapy/immunotherapy/ADC treatment etc. Receives: Radiation: Neoadjuvant radiotherapy; Combination Product: Neoadjuvant drug therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor response
The criteria for evaluating the efficacy of solid tumours classify the evaluation of the lesion into four scenarios: complete response, partial response, stable disease, progression.
Measured: 6 months
Secondary outcomes (2)
Disease free survival(DFS)
includes local recurrence, metastasis and death
Measured: through study completion, an average of 3 year
Adverse effects
Peri-treatment adverse effects and life quality scores
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start30 Jun 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Carcinoma of the Renal Pelvis and UreterStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuesong Li, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472752
- Sponsor's protocol ID
- LUXUS 7.0
- Acronym
- LUXUS07
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The raw data for this study will be stored within the www.3dmi.com and can be accessed by contacting the corresponding author for consent.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Neoadjuvant Radiotherapy for High-risk Upper Tract Urothelial Carcinoma: A Single-arm, Open Label, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06472752
- Acronym / sponsor ID
- LUXUS07 / LUXUS 7.0
- Keywords
- neoadjuvant radiotherapy, UTUC, prospective cohort, microenviroment, neoadjuvant combined therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 25 Jun 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.
The investigators propose to conduct an open-label, single-arm, prospective cohort study to collect and observe high-risk UTUC patients (with clear pathology of urothelial carcinoma and at least one of the following (muscle invasion [cT2 and above], high-grade tumour, multifocality, tumour diameter of ≥2cm, with hydronephrosis or regional lymph node metastasis) who undergo neoadjuvant therapy(neoadjuvant radiotherapy with/without drug) + radical nephroureterectomy. The cohort was evaluated by regular follow-up for safety and prognosis during the real-world neoadjuvant treatment period, perioperative period, and long-term postoperative follow-up.
Detailed description
The investigators propose to conduct an open-label, single-arm, prospective cohort study to collect and observe high-risk UTUC patients (with clear pathology of urothelial carcinoma and at least one of the following (muscle invasion [cT2 and above], high-grade tumour, multifocality, tumour diameter of ≥2cm, with hydronephrosis or regional lymph node metastasis) who undergo neoadjuvant therapy(neoadjuvant radiotherapy with/without drug like chemotherapy, immunotherapy or ADC and etc.) + radical nephroureterectomy. The cohort was evaluated by regular follow-up for safety and prognosis during the real-world neoadjuvant treatment period, perioperative period, and long-term postoperative follow-up.
Two cohorts will be enrolled in the project: Cohort 1: high-risk UTUC patients without distant metastases (may be accompanied by regional lymph node metastases) will receive a short course of neoadjuvant stereotactic radiotherapy (neoadjuvant SBRT) after completing a biopsy with a clear pathological diagnosis, and then undergo a radical surgery within 3 months after the completion of the last radiotherapy; Cohort 2: high-risk UTUC patients without distant metastases (may be accompanied by regional lymph node metastases) will receive short course neoadjuvant SBRT after completing a biopsy and making a clear pathological diagnosis. distant metastases (may be accompanied by regional lymph node metastases) of high-risk UTUC patients, who received short-course neoadjuvant stereotactic radiotherapy (neoadjuvant SBRT, naSBRT) + drug therapy after completing biopsy and clear pathological diagnosis, and were treated with radical surgical therapy (full-length radical nephroureterectomy + cystocele sleeve resection) within 3 months from the completion of the last radiotherapy treatment . Drug treatment could be chemotherapy/immunotherapy/ADC treatment etc.
Patients in both cohorts were evaluated by physicians after radical surgery for the need of additional adjuvant therapies (including but not limited to chemotherapy/immunotherapy/targeted or other molecular therapies, etc.) for 3 months after surgery based on pathological diagnosis, during which time the patients' adverse reactions and quality of life scores were closely monitored and recorded.
Postoperatively, each enrolled patient received regular review (including but not limited to CT, MRI, ultrasound, blood and urine routine, cystoscopy) every 3 months for 2 years after surgery and every 6 months for 3-5 years after surgery, as recommended by current guidelines. When target events including death, local recurrence (including retroperitoneal lymph node metastasis, recurrence in the tumour bed in the operation field, etc.), distant metastasis, bladder recurrence, etc. were observed then the time of the first observation and the corresponding type of event were recorded in detail, and the time interval from the start of the first neoadjuvant radiotherapy was calculated. At the same time, blood routine, lymphocyte typing information, blood and urine specimens, pre-operative biopsies and post-radical surgery pathology specimens were collected during the treatment period for the exploratory study of the corresponding molecular markers to evaluate the characteristics of patients' organism and the tumour immune microenvironment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant radiotherapy+radical surgery | – | Radiation: Neoadjuvant radiotherapyPatients with high-risk UTUC without distant metastases (which can be accompanied by regional lymph node metastases) were selected to receive short-course neoadjuvant stereotactic radiotherapy (neoadjuvant SBRT, naSBRT) after completion of biopsy and definitive pathological diagnosis, and to undergo radical surgery within 3 months from completion of the last radiotherapy session |
| Neoadjuvant radiotherapy and drug therapy+radical surgery | – | Radiation: Neoadjuvant radiotherapy, Combination Product: Neoadjuvant drug therapyPatients with high-risk UTUC without distant metastases (which may be accompanied by regional lymph node metastases) were selected to receive a short course of neoadjuvant stereotactic radiotherapy (neoadjuvant SBRT, naSBRT) + drug therapy after completing a biopsy and making a definitive pathological diagnosis, and to undergo a radical surgical procedure within 3 months from the end of the last radiotherapy session (full-length radical nephroureteral resection + cystocele sleeve resection ) treatment. Pharmacological treatment can be chemotherapy/immunotherapy/ADC treatment etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an open-label, single-arm, prospective cohort study, and the eligibility criteria for subjects to be included in the study are the same as the inclusion criteria. They will be informed of their informed consent and will voluntarily enrol in the study and sign an informed consent form prior to receiving their first treatment.
Key inclusion criteria (4 listed)
- ·≥18 years old, no gender limits, diagnosed as high-risk UTUC without existing distant metastasis or other malignancies;
- Completed pathological biopsy with a clear pathological diagnosis : including puncture biopsy, ureteroscopy and urine cytology, at least one of which is clearly diagnosed as uroepithelial carcinoma, which may include no more than 50% or more proportion of squamous, adenoid, sarcomatoid differentiation and other special differentiation types;
- Have the willingness to undergo radical surgical treatment and perioperative adjuvant treatment, have good compliance, and be able to co-operate with the treatment and follow-up plan specified by the clinician;
- Postoperative life expectancy of at least 6 months; ECOG score ≤ 2.
Key exclusion criteria (6 listed)
- Distant metastases or other malignant neoplastic diseases combined with other malignant neoplasms in the same period had been detected at the time of surgery, or the present was a progression after palliative resection of previous epithelial carcinoma of the urothelium;
- History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy;
- Pregnant women or breastfeeding women; or women of childbearing potential who are not using reliable contraception;
- The presence of active infections in those with pre-existing or coexisting haemorrhagic disorders
- 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);
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 |
|---|---|---|
| Neoadjuvant radiotherapyPatients with a clear pathological diagnosis of high-risk UTUC were treated with a short course of 5 days of naSBRT: radiotherapy irradiation was directed to the primary lesion on the affected side and to the lymphatic drainage area, with a dose of 25 Gy (5 Gy*5 days).The safety of the neoadjuvant radiotherapy dose and regimen can be evaluated by metrological ramping in the initial 5 patients, with subsequent patients following the optimal dose from ramping. | Radiation | Neoadjuvant radiotherapy and drug therapy+radical surgery, Neoadjuvant radiotherapy+radical surgery |
| Neoadjuvant drug therapyPatients will concurrently complete at least 2-4 cycles of preoperative neoadjuvant chemotherapy/immunotherapy/ADCs as well. | Combination product | Neoadjuvant radiotherapy and drug therapy+radical surgery |
Primary outcome
Local tumor response
Time frame: 6 months
The criteria for evaluating the efficacy of solid tumours classify the evaluation of the lesion into four scenarios: complete response, partial response, stable disease, progression.
2 secondary outcomes
Disease free survival(DFS)
Time frame: through study completion, an average of 3 year
Adverse effects
Time frame: Up to 1 year
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 25 Jun 2024.
- Individual participant dataSharing planned: Undecided. The raw data for this study will be stored within the www.3dmi.com and can be accessed by contacting the corresponding author for consent.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma of the Renal Pelvis and Ureter, run by Peking University First Hospital 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 25 Jun 2024. 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.
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?
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?
Local tumor response (time frame: 6 months). 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 25 Jun 2024.