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Neoadjuvant Radiotherapy for High-risk UTUC

ConditionUrothelial Carcinoma of the Renal Pelvis and Ureter
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University First Hospital

About this trial

The investigators propose to conduct an open-label, single-arm, prospective cohort study to collect and observe high-risk UTUC patients (with clear pathology of urothelial carcinoma and at least one of the following (muscle invasion \[cT2 and above\], high-grade tumour, multifocality, tumour diameter of ≥2cm, with hydronephrosis or regional lymph node metastasis) who undergo neoadjuvant therapy(neoadjuvant radiotherapy with/without drug) + radical nephroureterectomy. The cohort was evaluated by regular follow-up for safety and prognosis during the real-world neoadjuvant treatment period, perioperative period, and long-term postoperative follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Completed pathological biopsy with a clear pathological diagnosis : including puncture biopsy, ureteroscopy and urine cytology, at least one of which is clearly diagnosed as uroepithelial carcinoma, which may include no more than 50% or more proportion of squamous, adenoid, sarcomatoid differentiation and other special differentiation types;

Have the willingness to undergo radical surgical treatment and perioperative adjuvant treatment, have good compliance, and be able to co-operate with the treatment and follow-up plan specified by the clinician;

Postoperative life expectancy of at least 6 months; ECOG score ≤ 2.

Disqualifiers

Distant metastases or other malignant neoplastic diseases combined with other malignant neoplasms in the same period had been detected at the time of surgery, or the present was a progression after palliative resection of previous epithelial carcinoma of the urothelium;

History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy;

Pregnant women or breastfeeding women; or women of childbearing potential who are not using reliable contraception;

The presence of active infections in those with pre-existing or coexisting haemorrhagic disorders

Trial population

This is an open-label, single-arm, prospective cohort study, and the eligibility criteria for subjects to be included in the study are the same as the inclusion criteria. They will be informed of their informed consent and will voluntarily enrol in the study and sign an informed consent form prior to receiving their first treatment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Neoadjuvant radiotherapy

    Radiation

    Patients with a clear pathological diagnosis of high-risk UTUC were treated with a short course of 5 days of naSBRT: radiotherapy irradiation was directed to the primary lesion on the affected side and to the lymphatic drainage area, with a dose of 25 Gy (5 Gy\*5 days).The safety of the neoadjuvant radiotherapy dose and regimen can be evaluated by metrological ramping in the initial 5 patients, with subsequent patients following the optimal dose from ramping.

  • Neoadjuvant drug therapy

    Combination product

    Patients will concurrently complete at least 2-4 cycles of preoperative neoadjuvant chemotherapy/immunotherapy/ADCs as well.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Neoadjuvant radiotherapy+radical surgery1 intervention
Group B: Neoadjuvant radiotherapy and drug therapy+radical surgery2 interventions

Trial outcomes

Primary outcomes

1

Local tumor response

The criteria for evaluating the efficacy of solid tumours classify the evaluation of the lesion into four scenarios: complete response, partial response, stable disease, progression.

Time frame
6 months

Secondary outcomes

1

Disease free survival(DFS)

includes local recurrence, metastasis and death

Time frame
through study completion, an average of 3 year
2

Adverse effects

Peri-treatment adverse effects and life quality scores

Time frame
Up to 1 year

Other outcomes

1

Overall survival(OS)

Overall survival

Time frame
through study completion, an average of 3 year
2

Local recurrence free survival (LRFS)

Includes operational region recurrence and lymph nodes metastasis

Time frame
through study completion, an average of 3 year
3

Metastasis free survival (MFS)

Distant metastasis

Time frame
through study completion, an average of 3 year
4

Bladder recurrence free survival (BRFS)

Bladder recurrence free survival

Time frame
through study completion, an average of 3 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University First Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: