Trial Title:
Radiotherapy Combined with Systemic Therapy Versus Systemic Therapy for Oligometastatic UTUCs
NCT ID:
NCT06652022
Condition:
Oligometastatic Disease
Ureter Cancer
Renal Pelvic Carcinoma
Conditions: Official terms:
Carcinoma
Ureteral Neoplasms
Conditions: Keywords:
Oligometastatic Disease
Upper tract urothelial carcinoma
systematic
radiotherapy
Randomized control trial
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Systematic therapy combined with radiotherapy
Description:
Systematic medical therapy is same as the systematic treatment group. SBRT radiotherapy
or conventional fractionated radiotherapy can be used according to the extent and size of
the metastatic foci. SBRT radiotherapy is preferred, and a higher dose should be given as
far as possible when the normal tissues permit, with a preferred single dose of ≥5Gy.
Arm group label:
Systemic treatment combined with radiotherapy group
Intervention type:
Drug
Intervention name:
Systematic drug treatment
Description:
The choice of first-line treatment is based on the guidelines, and may include
chemotherapy or immune checkpoint inhibitors, or a combination of therapies. For patients
who can tolerate cisplatin, chemotherapy is given with the gemcitabine-cisplatin regimen,
as follows: gemcitabine 1000mg/m2 d1,8; cisplatin 70 mg/m2, avoiding light, intravenous
drip d2; 3 weeks for 1 cycle. For intolerant patients, the gemcitabine-carboplatin
regimen is given as follows: gemcitabine 1000 mg/m2 d1,8, IV, carboplatin (4.5×[GFR+25])
mg, IV, d1; 3 weeks as 1 cycle. Immune checkpoint inhibitors and targeted agents may be
administered if the patient does not tolerate chemotherapy; either in combination with
chemotherapy or directly as first line.
Arm group label:
Systemic treatment group
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.
Detailed 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with metastatic uroepithelial cancer with histologically confirmed
diagnosis (pathologically confirmed primary focus or one of the metastatic foci is
sufficient) (metastasis after total cystectomy, metastasis after full-length
nephroureteral resection, or metastatic uroepithelial cancer of the pelvic-ureteral
bladder at the first diagnosis of inoperable metastatic uroepithelial cancer).
- Oligometastases were defined as ≤3 organs, and the number and size of metastatic
lesions were not restricted to the extent that full-coverage radiotherapy could be
met. If regional lymph node recurrence was present, all positive regional lymph
nodes were collectively referred to as one lesion. Non-regional lymph node
metastases are counted as metastases by lymph node subregion.
- Willing and able to provide written informed consent/assent for the trial; age ≥18
years 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 blood
tests: a) Haemoglobin ≥ 90 g/L; b) Total bilirubin ≤ 2 x upper limit of normal
(ULN); c) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline
phosphatase (ALP) ≤ 2.5 x ULN in the absence of liver metastases, and ALT, AST and
ALP ≤ 5 x ULN in the presence of liver metastases; d) Creatinine clearance (CrCl)
≥30 mL/min;
Exclusion Criteria:
- Pathological type non-urothelial carcinoma;
- Patients with brain metastases and >3 liver metastases; patients with spinal bone
metastases at risk of spinal cord compression; patients with pericardial, pleural or
abdominopelvic fluid;
- Patients who are intolerant to or have had a reduction in systemic therapy; patients
with tumour progression assessed after 2 cycles of systemic therapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Departmeng of Urology, Peking University First Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuesong Li, M.D.
Phone:
+86-15801399116
Email:
pineneedle@sina.com
Contact backup:
Last name:
Chunru Xu, M.D.
Phone:
+86-17812172086
Email:
xcrbdyy@126.com
Facility:
Name:
Department of Radiotherapy Oncology, Peking University First Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xianshu Gao, M.D.
Phone:
+86-13716109164
Email:
doctorgaoxs@126.com
Contact backup:
Last name:
Xiaoying Li, M.D.
Phone:
+86-13716109164
Email:
13716109164@139.com
Start date:
January 1, 2022
Completion date:
December 30, 2029
Lead sponsor:
Agency:
Peking University First Hospital
Agency class:
Other
Source:
Peking University First Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06652022
