Radical Radiotherapy Versus Radical Surgery for UTUC

NCT06652009 | Recruiting DMC

• 1 other identifier: LUXUS6.0
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Renal Pelvis Cancer

Keywords

Renal pelvis carcinoma; Radical radiotherapy; Radical surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative changes in renal function(eGFR)

  Postoperative changes in renal function(eGFR)

  Immediately postoperatively, 1 month and 6-12 months postoperatively

Secondary Outcomes (4)

• Adverse effects

  1 month after the start of treatment until the end of treatment

• OS

  Until the end of the project, an average of 5 years; a mid-term analysis is usually implemented at the 3rd year.

• PFS

  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)

  1 month and 1 year after treatment

Study Arms (2)

Radical surgery group

Patients undergo radical nephroureterectomy

Other: Radical nephroureterectomy

Radical radiotherapy cohort

Patients undergo radical radiotherapy with stereotactic body radiation therapy (SBRT) or moderately segmented radiotherapy

Radiation: Radical radiotherapy

Interventions

Radical nephroureterectomy OTHER

Radical nephroureterectomy

Radical surgery group

Radical radiotherapy RADIATION

Radical radiotherapy with stereotactic body radiation therapy (SBRT) or moderately segmented radiotherapy

Radical radiotherapy cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (2)

Departmeng of Urology, Peking University First Hospital

Beijing, China

RECRUITING

Department of Radiotherapy Oncology, Peking University First Hospital

Beijing, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of the Department of Radiation Oncology

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: October 22, 2024
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 30, 2029
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (2)