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 (BLAD-RAD01)
Interventional
Phase 2
Institut Claudius Regaud (Voir sur ClinicalTrials)
juin 2020
juillet 2028
05 octobre 2024
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 | 04/09/2024 13:49:44 | Contacter | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Pierre BLANCHARD | 28/05/2024 16:24:30 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Francois Baclesse - Caen - France | Pierre-Emmanuel BRACHET | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - Lille - France | David PASQUIER | Contact (sur clinicalTrials) | |||
| Clinique Claude Bernard - Albi - France | Laurent VOTRON | Contact (sur clinicalTrials) | |||
| Institut Bergonie - Bordeaux - France | Paul SARGOS | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie de L'Ouest - Saint-Herblain - France | Valentine GUIMAS | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie Lucien Neuwirth - Saint-Priest-en-Jarez - France | Nicolas MAGNE | Contact (sur clinicalTrials) | |||
| Institut Universitaire du Cancer Toulouse Oncopole - Toulouse - 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 - France | Médéric BARRET | Contact (sur clinicalTrials) | |||
| CHU Besançon - Besançon - France | Jihane BOUSTANI | Contact (sur clinicalTrials) | |||
| Chu Morvan - Brest - France | Ulrike SCHICK | Contact (sur clinicalTrials) | |||
| Clinique Pasteur-Lanroze - Brest - France | Matthieu CHASSERAY | Contact (sur clinicalTrials) | |||
| Groupement de Radiothérapie et d'Oncologie des Pyrénées - Pau - France | Contact (sur clinicalTrials) | ||||
| HIA Bégin - Saint-Mandé - France | Hugo PICCHI | Contact (sur clinicalTrials) | |||
| Institut Andrée Dutreix - Dunkerque - France | Thomas MULLIEZ | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie de L'Ouest - Angers - France | Nathalie MESGOUEZ-NEBOUT | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - Marseille - France | Naji SALEM | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
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
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
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