Radical Radiotherapy Versus Radical Surgery for UTUC

October 20, 2024 updated by: LI xiaoying, Peking University First Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

1) 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.

3) 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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Departmeng of Urology, Peking University First Hospital
        • Contact:
        • Contact:
      • Beijing, China
        • Recruiting
        • Department of Radiotherapy Oncology, Peking University First Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Ureteral cancer of the renal pelvis in patients with advanced age, combined anaesthetic risk or regional lymph node metastases

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Radical surgery group
Patients undergo radical nephroureterectomy
Other: Radical nephroureterectomy
Radical nephroureterectomy
Radical radiotherapy cohort
Patients undergo radical radiotherapy with stereotactic body radiation therapy (SBRT) or moderately segmented radiotherapy
Radiation: Radical radiotherapy
Radical radiotherapy with stereotactic body radiation therapy (SBRT) or moderately segmented radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative changes in renal function(eGFR)
Time Frame: Immediately postoperatively, 1 month and 6-12 months postoperatively
Postoperative changes in renal function(eGFR)
Immediately postoperatively, 1 month and 6-12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects
Time Frame: 1 month after the start of treatment until the end of treatment
Adverse effects related to radiotherapy and surgery
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.
Overall survival
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.
Progression-free survival
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
Local response rate(LRR)
1 month and 1 year after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

October 20, 2024

First Posted (Actual)

October 22, 2024

Study Record Updates

Last Update Posted (Actual)

October 22, 2024

Last Update Submitted That Met QC Criteria

October 20, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUXUS6.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Pelvis Cancer

Clinical Trials on Radical nephroureterectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe