Status:
ACTIVE_NOT_RECRUITING
Adjuvant Radiotherapy in Patients With Pathological High-risk Bladder Cancer (GETUG-AFU 30)
Lead Sponsor:
UNICANCER
Conditions:
Patients With High-risk MIBC
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
INDICATION: Patients with pathological high-risk muscle invasive bladder cancer treated by radical cystectomy and pelvic lymph nodes dissection METHODOLOGY: Multicenter randomised phase II study in...
Eligibility Criteria
Inclusion
- To be eligible, the patients must fulfil all of the following inclusion criteria:
- 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.
Exclusion
- Patient must not be enrolled if he/she fulfils any of the following non-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.
Key Trial Info
Start Date :
April 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT03333356
Start Date
April 19 2018
End Date
December 1 2027
Last Update
December 4 2024
Active Locations (17)
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1
ICO Paul Papin
Angers, France, 49055
2
Institut Bergonie
Bordeaux, France, 33076
3
Centre Francois Baclesse
Caen, France, 14000
4
Centre Georges-Francois Leclerc
Dijon, France, 21079