Radiotherapy Combined with Systemic Therapy Versus Systemic Therapy for Oligometastatic UTUCs

Last updated: October 20, 2024
Sponsor: Peking University First Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Urothelial Tract Cancer

Urothelial Cancer

Treatment

Systematic therapy combined with radiotherapy

Systematic drug treatment

Clinical Study ID

NCT06652022
LUXUS5.0
  • Ages 18-80
  • All Genders

Study Summary

This study was a prospective, open-label, phase II randomised controlled clinical study, enrolling patients with primary oligometastatic uroepithelial carcinoma, oligometastasis was defined as ≤3 organs, and the number of metastatic lesions and size of metastases were not restricted to be able to satisfy the definition of full-coverage radiotherapy, with the exception of patients with brain metastases and more than 3 liver metastases.

If regional lymph node recurrence was present, all positive regional lymph nodes were collectively referred to as one lesion. Non-regional lymph node metastases were counted as the number of metastases by lymph node subregion.

Patients were divided into two groups according to whether they received radiotherapy or not: 1) systemic therapy group; 2) systemic therapy + radiotherapy group. Systemic drug therapy can be chosen from chemotherapy or immune checkpoint inhibitor therapy, or combination therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with metastatic uroepithelial cancer with histologically confirmeddiagnosis (pathologically confirmed primary focus or one of the metastatic foci issufficient) (metastasis after total cystectomy, metastasis after full-lengthnephroureteral resection, or metastatic uroepithelial cancer of the pelvic-ureteralbladder at the first diagnosis of inoperable metastatic uroepithelial cancer).

  • Oligometastases were defined as ≤3 organs, and the number and size of metastaticlesions were not restricted to the extent that full-coverage radiotherapy could bemet. If regional lymph node recurrence was present, all positive regional lymphnodes were collectively referred to as one lesion. Non-regional lymph nodemetastases are counted as metastases by lymph node subregion.

  • Willing and able to provide written informed consent/assent for the trial; age ≥18years on the date of signing the informed consent form and patient age ≤80 years.

  • Expected survival time ≥ 6 months;

  • Eastern Collaborative Oncology Group (ECOG) Physical Status (PS) score of 0 to 1;

  • Normal major organ function, i.e., the following criteria are met: routine bloodtests: a) Haemoglobin ≥ 90 g/L; b) Total bilirubin ≤ 2 x upper limit of normal (ULN); c) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkalinephosphatase (ALP) ≤ 2.5 x ULN in the absence of liver metastases, and ALT, AST andALP ≤ 5 x ULN in the presence of liver metastases; d) Creatinine clearance (CrCl) ≥30 mL/min;

Exclusion

Exclusion Criteria:

  • Pathological type non-urothelial carcinoma;

  • Patients with brain metastases and >3 liver metastases; patients with spinal bonemetastases at risk of spinal cord compression; patients with pericardial, pleural orabdominopelvic fluid;

  • Patients who are intolerant to or have had a reduction in systemic therapy; patientswith tumour progression assessed after 2 cycles of systemic therapy.

Study Design

Total Participants: 102
Treatment Group(s): 2
Primary Treatment: Systematic therapy combined with radiotherapy
Phase:
Study Start date:
January 01, 2022
Estimated Completion Date:
December 30, 2029

Study Description

This study was a prospective, open-label, phase II randomised controlled clinical study, enrolling patients with primary oligometastatic uroepithelial carcinoma, oligometastasis was defined as ≤3 organs, and the number of metastatic lesions and size of metastases were not restricted to be able to satisfy the definition of full-coverage radiotherapy, with the exception of patients with brain metastases and more than 3 liver metastases.

If regional lymph node recurrence was present, all positive regional lymph nodes were collectively referred to as one lesion. Non-regional lymph node metastases were counted as the number of metastases by lymph node subregion.

Patients were divided into two groups according to whether they received radiotherapy or not: 1) systemic therapy group; 2) systemic therapy + radiotherapy group. Systemic drug therapy can be chosen from chemotherapy or immune checkpoint inhibitor therapy, or combination therapy.

Connect with a study center

  • Departmeng of Urology, Peking University First Hospital

    Beijing,
    China

    Active - Recruiting

  • Department of Radiotherapy Oncology, Peking University First Hospital

    Beijing,
    China

    Active - Recruiting

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