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

NCT03333356 | Active Not Recruiting

• 2 other identifiers: UC-0160/16172016-A01535-46
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Patients With High-risk MIBC

Outcome Measures

Primary Outcomes (1)

• pelvic recurrence-free survival (PRFS)

  The PRFS is defined as the delay between randomization and pelvic recurrence or death, whichever occurs first. The pelvic recurrence will be evaluated according to RECIST V1.1 criteria.

  3 years

Secondary Outcomes (13)

• pelvic recurrence-free survival (PRFS)

  5 years

• Disease-free survival (DFS)

  3 years

• Disease-free survival (DFS)

  5 years

• Overall Survival (OS)

  3 years

• Overall Survival (OS)

  5 years

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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).

Radiation: pelvic radiotherapy

Standard Arm

NO INTERVENTION

Surveillance

Interventions

pelvic radiotherapy RADIATION

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).

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically-confirmed muscle-invasive bladder cancer, either with pure urothelial carcinomas, or dominant urothelial carcinomas (\>50%) combined with other histological variants including: micropapillary, epidermoid, or adenocarcinomas, are eligible. Patients with small cell variants, pure adenocarcinomas, or pure epidermoid carcinomas are not eligible.
• Patients with radical cystectomy and pelvic lymph nodes dissection with no microscopic residual disease (R0 and R1).
• Note that only R1 patients without urinary diversion as orthotropic neo-bladder replacement are eligible for the study, to limit cystectomy bed radiation induced toxicities.
• Patients with tumours of TNM staging: pN0-2, M0 by imagery, and pT3a, pT3b, pT4a, and pT4b, as well as, pTX-pN1-2, pTX-NX-R1 are eligible.
• Patients having received neo-adjuvant or adjuvant chemotherapy treatment are eligible. Randomization is allowed only if AE due to chemotherapy are ≤grade 2 at randomization.
• Patients ≥18 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• Absolute neutrophil count (ANC) ≥1500 cells/mm³.
• Platelets ≥100000 cells/mm³.
• Haemoglobin ≥8 g/dL (Note: following a blood transfusion or another intervention if required).
• Adequate hepatic function: aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤2.5 x upper limit of normal (ULN); or ≤3.5 x ULN in the case of concurrent disease with known etiology and for which a corrective treatment is possible.
• Adequate renal function: clearance \>30 mL/min (MDRD).
• Patients having provided written informed consent prior to any study-related procedures.
• Patients affiliated to the social security scheme.
• Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (17)

ICO Paul Papin

Angers, 49055, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Francois Baclesse

Caen, 14000, France

Location

Centre Georges-Francois Leclerc

Dijon, 21079, France

Location

Chu Grenoble

Grenoble, 38043, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Hôpital Universitaire Dupuytren

Limoges, 87042, France

Location

Groupe Hospitalier Bretagne Sud

Lorient, 56100, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

CHU La Timone

Marseille, 13385, France

Location

Saint Louis

Paris, 75010, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Chp Saint-Gregoire

Saint-Grégoire, 35760, France

Location

ICO - site René Gauducheau

Saint-Herblain, 44805, France

Location

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

Location

Institut Claudius Regaud

Toulouse, 31059, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Study Officials

• Paul SARGOS, MD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

• Stéphane LARRE, Prof

  CHU Robert Debré

  PRINCIPAL INVESTIGATOR

• Géraldine PIGNOT, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 6, 2017
• Study Start: April 19, 2018
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

FR (17)