Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy: a Prospective Randomized Comparative Phase II Trial

Institut Claudius Regaud19 sites in 1 country130 target enrollmentJune 30, 2020

ConditionsUrothelial Bladder Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Urothelial Bladder Cancer
Sponsor: Institut Claudius Regaud
Enrollment: 130
Locations: 19
Primary Endpoint: Overall Survival
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase II, multicenter, randomized open-label and comparative study that has been designed to evaluate whether local consolidative radiotherapy in addition to standard of care improves overall survival as compared with standard of care in patients with regional and/or distant metastatic urothelial bladder cancer who have no disease progression and with no more than three residual distant metastatic lesions following the initial phase of first-line systemic therapy.

Each patient will be followed during 4 years from the date of randomization.

Registry

clinicaltrials.gov

Start Date

June 30, 2020

End Date

July 1, 2031

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Institut Claudius Regaud

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years
•Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
•Urothelial bladder cancer histologically proven (both pure urothelial cancers and mixed histologic features are allowed)
•Metastatic patients to regional nodes (Tx,N1-N3,M0) and/or distant sites (Tx,Nx,M1a-M1b) documented with contrast-enhanced CT-scanner of the chest, abdomen and pelvis, either de novo or presenting first regional/distant relapse following cystectomy (with no local recurrence in the cystectomy bed)
•Completion of the initial phase (4-6 cycles) of 1st line metastatic treatment (systemic therapy by chemotherapy and/or immunotherapy by immune check-point inhibitor according to standard recommendations). Patients having started maintenance therapy are eligible.
•No disease progression after the initial phase of first-line metastatic systemic therapy according to RECIST v1.1
•No more than 3 residual distant metastatic lesions following the initial phase of first-line metastatic systemic therapy:
•Regional nodes (below aortic bifurcation) are not included in the count of distant metastatic lesions
•The number of distant residual lesions is determined on the basis of the imaging modality for tumor response assessment performed after systemic treatment according to local habits (CT-scan or 18FDG PET-CT if performed):
•In case of response assessment by CT-scanner only: residual lesions are all remaining visible lesions In case of response assessment by additional 18FDG PET-CT: residual lesions are only the lesions with residual hyperfixation

Exclusion Criteria

•Non-transitional cell histology (Squamous cell carcinoma, adenocarcinoma or neuroendocrine carcinoma of the bladder)
•Brain metastases before systemic treatment
•Liver metastases before systemic treatment
•Absence of target to be irradiated (i.e. previous cystectomy + no residual distant lesions following systemic treatment + no pelvic or para-aortic nodes at metastatic presentation)
•Patient with relapse following definitive chemoradiation of the bladder
•Local recurrence in the cystectomy bed following cystectomy
•Previous pelvic irradiation
•Prior radiotherapy near the residual metastatic lesions precluding ablative SBRT
•Active inflammatory bowel disease
•Contraindication to SBRT of a lesion due to organ dysfunction; in particular, patients with lung lesions and documented or suspected interstitial lung disease should not be included

Outcomes

Primary Outcomes

Overall Survival

Time Frame: 4 years for each patient

Secondary Outcomes

Progression Free Survival(4 years for each patient)
Quality of life will be evaluated by the EORTC QLQ-C-30 questionnaire(4 years for each patient)
Safety will be assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5)(4 years for each patient)