Adjuvant Radiotherapy and Combined Adjuvant Treatment Strategy for UTUC

November 2, 2023 updated by: Xuesong Li, Peking University First Hospital

Safety and Efficacy of Adjuvant Radiotherapy and Combined Adjuvant Treatment Strategy for Upper Tract Urothelial Carcinoma: An Ambispective Cohort Study

This study is an ambispective cohort observational study to analyze the efficacy of surgery alone versus postoperative adjuvant therapy (postoperative radiotherapy/postoperative chemotherapy(immunotherapy)/ combined strategy) in patients with the upper urinary tract urothelial carcinoma with high-risk factors (postoperative pathology suggestive of pT2 and above, N+, G3/high-grade and multiple tumors, positive cut margins). A subgroup analysis was performed to obtain the population of patients who might benefit from different treatment approaches. Patients with high risk factors for postoperative recurrence or metastasis will be treated with relevant adjuvant therapy, which in turn will benefit patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is an ambispective cohort observational study to analyze the efficacy of surgery alone versus postoperative adjuvant therapy (postoperative radiotherapy/postoperative chemotherapy(immunotherapy)/ combined strategy) in patients with the upper urinary tract urothelial carcinoma with high-risk factors (postoperative pathology suggestive of pT2 and above, N+, G3/high-grade and multiple tumors, positive cut margins). A subgroup analysis was performed to obtain the population of patients who might benefit from different treatment approaches. Patients with high risk factors for postoperative recurrence or metastasis will be treated with relevant adjuvant therapy, which in turn will benefit patients.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chunru Xu, M.D.
  • Phone Number: +8617812172086
  • Email: xcrbdyy@126.com

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Department of Medical Oncology, Peking University First Hospital
        • Contact:
        • Contact:
      • Beijing, China
        • Recruiting
        • Departmeng of Urology, Peking University First Hospital
        • Contact:
        • Contact:
      • Beijing, China
        • Recruiting
        • Department of Radiotherapy Oncology, Peking University First Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

High-risk UTUC patients (met at least one of indications such as: 1. pT2+, 2.G3/High-grade, 3.Multifocality, 4. Positive surgical margin, 5. Positive lymph-node metastasis

Description

Inclusion Criteria:

  • 1. Confirmed pathologic diagnosis as upper urinary tract urothelial carcinoma(UTUC), without any serious complication; 2. Meet any of the following conditions: >= pT2,pN+,tumor G3 grade, multifocality or positive surgical margins (according to AJCC 8th edition); 3. Aged >= 18 years old;

Exclusion Criteria:

  • 1. Distant metastases already found at the time of surgery; non-R0 resected patients; 2. History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; 3. Pregnant or lactating women; or women of childbearing potential who are not using reliable contraception; 4. History of malignant tumors (except skin cancer that is not malignant melanoma and in situ cervical cancer, tumors that have been cured for more than 5 years); 5. Weight loss > 10% within 6 months; 6. Existing or coexisting bleeding disorders, active infection; 7. Clinically significant cardiac disease (e.g., hypertension controlled with medications, unstable angina, New York Heart Association (NYHA) >= Class II congestive heart failure, unstable symptomatic arrhythmia, or >=Class II peripheral vascular disease); 8. Those who are unable to sign informed consent due to psychological, family, social and other factors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surveillance alone
Participants underwent radical total nephroureterectomy alone (with or without lymph node dissection) without postoperative adjuvant therapy
Adjuvant chemotherapy/immunotherapy
Participants underwent radical total nephroureterectomy and adjuvant chemotherapy/immunotherapy postoperatively.
Drug: Chemotherapy and immunotherapy

For patients eligible for enrollment, postoperative adjuvant chemotherapy was initiated at about 4-6 weeks after surgery, for a total of 4 cycles, with the chemotherapy regimen of gemcitabine + cisplatin. Administration: Gemcitabine 1,000 mg/m2 on days 1 and 8 (completed within 30-60 minutes), cisplatin 70 mg/m2 on day 1.

Immunotherapeutic agents include (PD-1/PD-L1) to be used every 21 days postoperatively for one year.
Adjuvant radiotherapy
Participants underwent radical total nephroureterectomy and adjuvant radiotherapy postoperatively.
Radiation: Radiotherapy

For participants eligible for enrollment, radiotherapy was started within 4-6 weeks after surgery. Rotational intensity-modulated radiotherapy (VMAT) with daily image-guided radiotherapy (Daily IGRT) technique was used.

Range of irradiation (patients were randomized into two groups - expanded field irradiation group and involved field irradiation group)
Adjuvant combined therapy
Participants underwent radical total nephroureterectomy (with or without lymph node dissection) with a combination of adjuvant chemotherapy/immunotherapy and radiation therapy postoperatively
Combination product: Combined adjuvant therapy
For patients eligible for enrollment, sequential adjuvant radiotherapy (same as the radiotherapy group) and systemic drug therapy (same as the chemotherapy group; immunotherapy drugs can be PD-1 or PDL-1) can be started at about 4-6 weeks after surgery. The specific dose of drugs can be adjusted according to the actual tolerability of the patient, such as reducing or replacing the regimen, or interrupting the regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 1-year, 3-year and 5-year
Progression-free Survival
1-year, 3-year and 5-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 1-year, 3-year and 5-year
Overall survival
1-year, 3-year and 5-year
CSS
Time Frame: 1-year, 3-year and 5-year
Cancer specific survival
1-year, 3-year and 5-year
LRFS
Time Frame: 1-year, 3-year and 5-year
Local recurrence free survival
1-year, 3-year and 5-year
MFS
Time Frame: 1-year, 3-year and 5-year
Metastasis free survival
1-year, 3-year and 5-year
IRFS and CRFS
Time Frame: 1-year, 3-year and 5-year
intravesical-recurrence free survival and contralateral-recurrence free survival
1-year, 3-year and 5-year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
AE
Time Frame: Peri-therapeutic period
Adverse effects
Peri-therapeutic period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Principal Investigator: Xiaoying Li, M.D., Department of Radiotherapy Oncology, Peking University First Hospital
  • Study Chair: Liqun Zhou, M.D., Department of Urology, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2023

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2028

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

November 2, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUXUS2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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