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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)

Primary Purpose

Urothelial Bladder Cancer

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Experimental arm
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urothelial Bladder Cancer focused on measuring Urothelial bladder cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (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)
  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 metastatic lesions following the initial phase of first-line metastatic systemic therapy:

    1. 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

    2. 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 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 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 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])
  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

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

Arm Type

No Intervention

Experimental

Arm Label

Control arm

Experimental arm

Arm Description

Standard of care

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Progression Free Survival
Safety will be assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5)
Quality of life will be evaluated by the EORTC QLQ-C-30 questionnaire

Full Information

First Posted
June 9, 2020
Last Updated
September 20, 2023
Sponsor
Institut Claudius Regaud
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1. Study Identification

Unique Protocol Identification Number
NCT04428554
Brief Title
Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy
Acronym
BLAD-RAD01
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
July 2028 (Anticipated)
Study Completion Date
July 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a phase II, multicenter, randomized open-label and comparative study designed to evaluate whether local consolidative radiotherapy plus standard of care improves overall survival as compared to standard of care in patients with limited metastatic urothelial bladder cancer and without progression following the initial phase of first-line systemic therapy. Each patient will be followed during 4 years from the date of randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Bladder Cancer
Keywords
Urothelial bladder cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Standard of care
Arm Title
Experimental arm
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Experimental arm
Intervention Description
Consolidative radiotherapy (pelvic irradiation and/or metastases irradiation) + standard of care +/- previous transurethral resection of bladder tumor
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
4 years for each patient
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
4 years for each patient
Title
Safety will be assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5)
Time Frame
4 years for each patient
Title
Quality of life will be evaluated by the EORTC QLQ-C-30 questionnaire
Time Frame
4 years for each patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan KHALIFA
Phone
05 31 15 54 01
Email
khalifa.jonathan@iuct-oncopole.fr
Facility Information:
Facility Name
Clinique Claude Bernard
City
Albi
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent VOTRON
Phone
05 63 77 77 56
Email
votron@claude-bernard-albi.com
Facility Name
Institut de Cancerologie de L'Ouest
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie MESGOUEZ-NEBOUT
Phone
02 41 35 27 00
Email
thalie.mesgouez-nebout@ico-unicancer.fr
Facility Name
CHU Besançon
City
Besançon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jihane BOUSTANI
Phone
03 70 63 23 23
Email
jboustani@chu-besançon.fr
Facility Name
Institut Bergonie
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul SARGOS
Phone
05 56 33 33 33
Email
P.Sargos@bordeaux.unicancer.fr
Facility Name
Chu Morvan
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrike SCHICK
Email
ulrike.schick@chu-brest.fr
Facility Name
Clinique Pasteur-Lanroze
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthieu CHASSERAY
Phone
02 98 31 30 07
Email
m.chasseray@oncologie-brest.fr
Facility Name
Centre Francois Baclesse
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Emmanuel BRACHET
Phone
02 31 45 50 02
Email
pe.brachet@baclesse.unicancer.fr
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica MIROIR
Phone
04 73 27 81 42
Email
jessica.miroir@clermont.unicancer.fr
Facility Name
Institut Andrée Dutreix
City
Dunkerque
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas MULLIEZ
Phone
03 28 51 96 30
Email
thomasmulliez@hotmail.com
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David PASQUIER
Phone
03 20 29 51 44
Email
d-pasquier@o-lambret.fr
Facility Name
Institut Paoli-Calmettes
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naji SALEM
Phone
04 91 22 36 37
Email
salemn@ipc.unicancer.fr
Facility Name
Centre Antoine Lacassagne
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Médéric BARRET
Phone
04 92 03 12 60
Email
mederic.barret@nice.unicancer.fr
Facility Name
Institut Curie
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles CREHANGE
Phone
01 72 38 94 45
Email
gilles.crehange@curie.fr
Facility Name
Groupement de Radiothérapie et d'Oncologie des Pyrénées
City
Pau
Country
France
Individual Site Status
Withdrawn
Facility Name
Institut de Cancerologie de L'Ouest
City
Saint-Herblain
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentine GUIMAS
Phone
02 40 57 99 55
Email
valentine.guimas@ico.unicancer.fr
Facility Name
HIA Bégin
City
Saint-Mandé
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo PICCHI
Phone
01 86 93 75 20
Email
picchi.hugo90@gmail.com
Facility Name
Institut de Cancerologie Lucien Neuwirth
City
Saint-Priest-en-Jarez
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas MAGNE
Phone
04 77 91 74 25
Email
nicolas.magne@icloire.fr
Facility Name
Institut Universitaire du Cancer Toulouse Oncopole
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan KHALIFA
Phone
05 31 15 54 29
Email
khalifa.jonathan@iuct-oncopole.fr
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre BLANCHARD
Phone
01 42 11 44 13
Email
pierre.blanchard@gustaveroussy.fr

12. IPD Sharing Statement

Learn more about this trial

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

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