Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
Institut Claudius Regaud (Voir sur ClinicalTrials)
juin 2020
juillet 2031
02 décembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:13 | Contacter | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Pierre BLANCHARD | 28/05/2024 16:24:30 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CLINIQUE CLAUDE BERNARD | Laurent VOTRON | Contact (sur clinicalTrials) | |||
| GH PARIS SITE SAINT JOSEPH | Constance MICHEL, Dr | Contact (sur clinicalTrials) | |||
| INSTITUT GUSTAVE ROUSSY | Pierre BLANCHARD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Jean Perrin - Clermont-Ferrand 3024635 - France | Contact (sur clinicalTrials) | ||||
| CHRU Brest - Brest 3030300 - France | Ulrike SCHICK | Contact (sur clinicalTrials) | |||
| CHU Besançon - Besançon 3033123 - France | Jihane BOUSTANI | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie de L'Ouest - Angers 3037656 - France | Nathalie MESGOUEZ-NEBOUT | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie de L'Ouest - Saint-Herblain 2979590 - France | Valentine GUIMAS | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie Lucien Neuwirth - Saint-Priest-en-Jarez 2977350 - France | Nicolas MAGNE | Contact (sur clinicalTrials) | |||
| Institut Universitaire du Cancer Toulouse Oncopole - Toulouse 2972315 - France | Jonathan KHALIFA | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - Nice 2990440 - France | Médéric BARRET | Contact (sur clinicalTrials) | |||
| Centre Francois Baclesse - Caen 3029241 - France | Pierre-Emmanuel BRACHET | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - Lille 2998324 - France | Contact (sur clinicalTrials) | ||||
| Clinique Pasteur-Lanroze - Brest 3030300 - France | Matthieu CHASSERAY | Contact (sur clinicalTrials) | |||
| Groupement de Radiothérapie et d'Oncologie des Pyrénées - Pau 2988358 - France | Contact (sur clinicalTrials) | ||||
| HIA Bégin - Saint-Mandé 2978621 - France | Hugo PICCHI | Contact (sur clinicalTrials) | |||
| Institut Andrée Dutreix - Dunkirk 3020686 - France | Thomas MULLIEZ | Contact (sur clinicalTrials) | |||
| Institut Bergonie - Bordeaux 3031582 - France | Paul SARGOS | Contact (sur clinicalTrials) | |||
| Institut Curie - Paris 2988507 - France | Gilles CREHANGE | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - Marseille 2995469 - France | Naji SALEM | Contact (sur clinicalTrials) | |||
Critères
Tous
1. Age ≥ 18 years
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
3. Urothelial bladder cancer histologically proven (both pure urothelial cancers and
mixed histologic features are allowed)
4. 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)
5. 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.
6. No disease progression after the initial phase of first-line metastatic systemic
therapy according to RECIST v1.1
7. No more than 3 residual distant metastatic lesions following the initial phase of
first-line metastatic systemic therapy:
1. Regional nodes (below aortic bifurcation) are not included in the count of
distant metastatic lesions
2. 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
3. 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.
8. 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
9. 8 weeks or less between last cycle of the initial phase of systemic treatment and
randomization
10. No contraindication to pelvic radiotherapy
11. Signed informed consent
12. Patient able to participate and willing to give informed consent prior performance
of any study-related procedures and to comply with the study protocol
13. Patient affiliated to a Social Health Insurance in France
Exclusion Criteria:
1. Non-transitional cell histology (Squamous cell carcinoma, adenocarcinoma or
neuroendocrine carcinoma of the bladder)
2. Brain metastases before systemic treatment
3. Liver metastases before systemic treatment
4. 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)
5. Patient with relapse following definitive chemoradiation of the bladder
6. Local recurrence in the cystectomy bed following cystectomy
7. Previous pelvic irradiation
8. Prior radiotherapy near the residual metastatic lesions precluding ablative SBRT
9. Active inflammatory bowel disease
10. 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
11. History of scleroderma
12. 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])
13. Pregnancy or breast feeding or inadequate contraceptive measures
14. Known psychiatric or substance abuse disorders that would interfere with cooperation
with the requirements of the trial.
15. 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
16. Patient who has forfeited his/her freedom by administrative or legal award or who is
under legal protection (curatorship and guardianship, protection of justice).
17. Concurrent enrolment in another interventional therapeutic clinical study