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

  • STATUS
    Recruiting
  • End date
    Jan 26, 2026
  • participants needed
    109
  • sponsor
    UNICANCER
Updated on 26 January 2021
Investigator
Sandra Pelissier
Primary Contact
Clinique Pasteur Cfro (0.6 mi away) Contact
+28 other location

Summary

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.

Details
Condition Patients With High-risk MIBC, Patients With High-risk MIBC, Patients With High-risk MIBC, Patients With High-risk MIBC, Patients With High-risk MIBC, Patients With High-risk MIBC
Treatment Pelvic Radiotherapy
Clinical Study IdentifierNCT03333356
SponsorUNICANCER
Last Modified on26 January 2021

Eligibility

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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