Adjuvant Radiotherapy in Patients With Pathological High-risk Bladder Cancer (GETUG-AFU 30) (Bladder-ART)

  • End date
    Dec 6, 2027
  • participants needed
  • sponsor
Updated on 3 March 2022


This is a randomized multicentre study in patients with high-risk MIBC to investigate adjuvant radiotherapy after radical cystectomy and pelvic lymph node dissection.

The objective of the study is to provide evidence that adjuvant radiotherapy improves loco-regional control with potential benefits in survival. The study will also evaluate the quality of life of patients and the tolerance of the treatment.



Patients with pathological high-risk muscle invasive bladder cancer treated by radical cystectomy and pelvic lymph nodes dissection


Multicenter randomised phase II study in high-risk bladder cancer patients treated by radical cystectomy with pelvic lymph nodes dissection assessing :

  • Experimental Arm: adjuvant pelvic radiotherapy consisting of 28 x 1.8 Gy fractions (total dose of 50.4 Gy), 5 days per week, 1 fraction /day (duration of RT is 38 days).
  • Standard Arm: surveillance. Eligible patients will be randomised, in a 3:1 ratio, to receive either: adjuvant pelvic radiotherapy (Experimental Arm), or surveillance (Standard Arm).


The primary objective of the trial is to assess the efficacy of adjuvant radiotherapy in patients with high-risk bladder cancer after radical cystectomy and pelvic lymph nodes dissection. Efficacy will be assessed in terms of pelvic recurrence-free survival (PRFS) at 3 years.


For each treatment arm (adjuvant pelvic radiotherapy [Experimental Arm], or surveillance [Standard Arm]), these objectives will be evaluated independently.

  • To evaluate 5-year pelvic recurrence-free survival (PRFS)
  • To evaluate disease-free survival (DFS) at 3 and 5 years.
  • To evaluate overall survival (OS) at 3 and 5 years.
  • To evaluate metastasis-free survival (MFS) at 3 and 5 years.
  • To evaluate disease-specific survival (DSS) at 3 and 5 years.
  • To evaluate the tolerance and safety of each treatment strategy.
  • To evaluate patients' quality of life.

Ancillary studies Objectives:

  • Investigation of individual predisposition to develop radiotherapy induced late digestive toxicity using the radiation-induced lymphocyte apoptosis (RILA) assay
  • The analyse of genomic and transcriptome correlation between different clusters and oncological outcomes
  • Dosimetric banking to evaluate the correlation of Dose-Volume Histogram with:
  • Gastrointestinal toxicity grade 2;
  • Pelvic recurrence (radiotherapy volumes, mapping of recurrences).

Condition Patients With High-risk MIBC
Treatment Pelvic Radiotherapy
Clinical Study IdentifierNCT03333356
Last Modified on3 March 2022


Yes No Not Sure

Inclusion Criteria

Patients with R1 resection and with orthotropic neo-bladder reconstruction as urinary diversion are not eligible
Patients with clinical or radiological evidence of metastases or N3 staged bladder cancer are not eligible
Prior invasive solid tumours or haematological malignancies unless disease free for a minimum of 3 years prior to randomisation except
skin basal cell carcinoma
in situ epithelioma of the cervix
or prostate cancer: incidentally discovered during cystoprostatectomy and pelvic lymph node dissection and with a good prognosis (T stage <pT3b and/or Gleason <8 and pN- and/or post-operative prostate-specific antigen (PSA) <0.1 nanogram/mL)
Prior pelvic radiotherapy
Patients with active inflammatory bowel disease
Patients who required surgical treatment for bowel obstruction before bladder cancer diagnosis or after cystectomy
Prior chemotherapy for other malignant diseases within the previous 5 years, except for neoadjuvant pre-cystectomy chemotherapy or adjuvant chemotherapy which are permitted
Patients with the following severe acute co-morbidity are not eligible
Unstable angina or congestive heart failure that required hospitalization in the 6 months before randomisation
Transmural myocardial infarction in the 6 months prior to randomisation
Acute bacterial or fungal infection requiring intravenous antibiotics at randomisation
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of randomisation
Severe hepatic disease: Child-Pugh Class B or C hepatic disease
Known acquired immune deficiency syndrome (AIDS); the study treatment could impact blood count
Patients with any other disease or illness which requires hospitalization or is incompatible with the study treatment are not eligible
Patients unable to comply with study obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the study
Patients enrolled in another therapeutic study within 30 days prior of randomisation
Person deprived of their liberty or under protective custody or guardianship

Exclusion Criteria

Patient must not be enrolled if he/she fulfils any of the following non-
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