Radiotherapy Combined with Systemic Therapy Versus Systemic Therapy for Oligometastatic UTUCs
NCT ID: NCT06652022
Last Updated: 2024-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
102 participants
INTERVENTIONAL
2022-01-01
2029-12-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Systemic treatment group
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.
Systematic drug treatment
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.
Systemic treatment combined with radiotherapy group
For patients with oligometastases, the radiotherapy protocol adopts a full-coverage radiotherapy protocol for metastatic foci, which is used as early as possible during the 2 cycles of systemic treatment for the patients. For retroperitoneal lymph node metastases, the conventional segmental radiotherapy protocol is used, and for isolated metastatic foci, the SBRT radiotherapy is used as much as possible.
PETCT was used to determine the location and number of metastatic foci before radiotherapy, and for some patients who could not undergo PETCT, chest, abdominal and pelvic CT, ultrasound of superficial lymph nodes, bone scanning and cranial MRI were used to define the scope of the patient's foci.
Systematic therapy combined with radiotherapy
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.
Interventions
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Systematic therapy combined with radiotherapy
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.
Systematic drug treatment
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Responsible Party
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LI xiaoying
Vice Director of the Department of Radiation Oncology
Locations
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Departmeng of Urology, Peking University First Hospital
Beijing, , China
Department of Radiotherapy Oncology, Peking University First Hospital
Beijing, , China
Countries
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Facility Contacts
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Other Identifiers
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LUXUS5.0
Identifier Type: -
Identifier Source: org_study_id
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