Status:
RECRUITING
Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Urothelial Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 overal...
Eligibility Criteria
Inclusion
- 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
- 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 distant metastases (if applicable) eligible for SBRT in terms of dose constraints to the organs at risk, with no prior radiotherapy interfering with SBRT
- 8 weeks or less between last cycle of the initial phase 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
- 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
- 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 cystoprostatetectomy 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
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2031
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04428554
Start Date
June 30 2020
End Date
July 1 2031
Last Update
November 18 2025
Active Locations (20)
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1
Clinique Claude Bernard
Albi, France
2
Institut de Cancerologie de L'Ouest
Angers, France
3
CHU Besançon
Besançon, France
4
Institut Bergonie
Bordeaux, France