Consolidative Radiotherapy Versus Observation for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Institut Claudius Regaud
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Updated on 19 February 2024
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Summary

This is a phase II, multicenter, randomized open-label and comparative study designed to evaluate whether local consolidative radiotherapy improves overall survival as compared with standard management in patients with limited metastatic urothelial bladder cancer and without progression following first-line systemic therapy.

Each patient will be followed during 3 years from the date of randomization.

Details
Condition Urothelial Bladder Cancer
Age 18-100 years
Treatment Experimental Arm
Clinical Study IdentifierNCT04428554
SponsorInstitut Claudius Regaud
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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 (AJCC v8: M1a or M1b) documented with contrast-enhanced CT-scanner of the chest, abdomen and pelvis, either de novo or presenting first distant relapse following cystectomy (with no local recurrence in the cystectomy bed) more than 6 months after completion of peri-operative chemotherapy
Completion of the 1st line metastatic treatment (systemic therapy by chemotherapy and/or immunotherapy by immune check-point inhibitor according to standard recommendations)
No disease progression after standard first-line systemic therapy according to RECIST v1.1
No more than 3 residual metastatic lesions following standard first-line systemic
therapy
The number of 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
\. Regarding distant lymph nodes metastases
If evaluation is performed by CT-scanner only, residual lymph nodes are
considered pathological according to one or several criteria among
Short axis 1cm
Central necrosis
Heterogeneous contrast enhancement
Residual para-aortic nodes involvement accounts for one lesion, even if
several para-aortic nodes are involved
Other nodes: each involved node accounts for one lesion
\. Residual metastases (if applicable) eligible for SBRT in terms of dose
constraints to the organs at risk, with no prior radiotherapy interfering with
SBRT
\. 6 weeks or less between last cycle of systemic treatment and randomization
\. No contraindication to pelvic radiotherapy
\. Signed informed consent
\. Patient able to participate and willing to give informed consent prior
performance of any study-related procedures and to comply with the study
protocol
\. Patient affiliated to a Social Health Insurance in France

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 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
History of scleroderma
Current or past history of second neoplasm diagnosed within the last 5 years (except basocellular carcinoma and prostate cancer incidentally discovered during previous cystoprostatectomy and pelvic lymph node dissection and with a good prognosis [T stage <pT3b and Gleason <8 and pN- and post-operative PSA <0.1 ng/mL])
Pregnancy or breast feeding or inadequate contraceptive measures
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
Concurrent enrolment in another interventional therapeutic clinical study
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