Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy (BLAD-RAD01)
Urothelial Bladder Cancer
About this trial
This is an interventional treatment trial for Urothelial Bladder Cancer focused on measuring Urothelial bladder cancer
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 (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)
- 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 metastatic lesions following the initial phase of first-line metastatic 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
- 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 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
Sites / Locations
- Clinique Claude BernardRecruiting
- Institut de Cancerologie de L'OuestRecruiting
- CHU BesançonRecruiting
- Institut BergonieRecruiting
- Chu MorvanRecruiting
- Clinique Pasteur-LanrozeRecruiting
- Centre Francois BaclesseRecruiting
- Centre Jean PerrinRecruiting
- Institut Andrée DutreixRecruiting
- Centre Oscar Lambret
- Institut Paoli-CalmettesRecruiting
- Centre Antoine LacassagneRecruiting
- Institut CurieRecruiting
- Groupement de Radiothérapie et d'Oncologie des Pyrénées
- Institut de Cancerologie de L'OuestRecruiting
- HIA BéginRecruiting
- Institut de Cancerologie Lucien Neuwirth
- Institut Universitaire du Cancer Toulouse OncopoleRecruiting
- Institut Gustave RoussyRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control arm
Experimental arm
Standard of care