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)

February 1, 2024 updated by: Institut Claudius Regaud

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Albi, France
      • Angers, France
      • Besançon, France
      • Bordeaux, France
      • Brest, France
      • Brest, France
      • Caen, France
      • Clermont-Ferrand, France
        • Withdrawn
        • Centre Jean Perrin
      • Dunkerque, France
      • Lille, France
        • Not yet recruiting
        • Centre Oscar Lambret
        • Contact:
      • Marseille, France
        • Recruiting
        • Institut Paoli-Calmettes
        • Contact:
      • Nice, France
      • Paris, France
      • Pau, France
        • Withdrawn
        • Groupement de Radiothérapie et d'Oncologie des Pyrénées
      • Saint-Herblain, France
      • Saint-Mandé, France
      • Saint-Priest-en-Jarez, France
        • Not yet recruiting
        • Institut de Cancérologie Lucien Neuwirth
        • Contact:
      • Toulouse, France
      • Villejuif, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
Radiation: Experimental arm
Consolidative radiotherapy (pelvic irradiation and/or metastases irradiation) + standard of care +/- previous transurethral resection of bladder tumor
No Intervention: Control arm
Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 4 years for each patient
4 years for each patient

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: 4 years for each patient
4 years for each patient
Safety will be assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5)
Time Frame: 4 years for each patient
4 years for each patient
Quality of life will be evaluated by the EORTC QLQ-C-30 questionnaire
Time Frame: 4 years for each patient
4 years for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2020

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

June 9, 2020

First Submitted That Met QC Criteria

June 10, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19 URO 15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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