Adjuvant Radiotherapy in Patients With Pathological High-risk Bladder Cancer (GETUG-AFU 30)
NCT ID: NCT03333356
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
81 participants
INTERVENTIONAL
2018-04-19
2027-12-31
Brief Summary
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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.
Detailed Description
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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 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).
PRIMARY OBJECTIVE:
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.
SECONDARY OBJECTIVES:
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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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).
pelvic radiotherapy
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
No interventions assigned to this group
Interventions
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pelvic radiotherapy
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).
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. 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.
5. Patients ≥18 years old.
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
7. Absolute neutrophil count (ANC) ≥1500 cells/mm³.
8. Platelets ≥100000 cells/mm³.
9. Haemoglobin ≥8 g/dL (Note: following a blood transfusion or another intervention if required).
10. 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.
11. Adequate renal function: clearance \>30 mL/min (MDRD).
12. Patients having provided written informed consent prior to any study-related procedures.
13. Patients affiliated to the social security scheme.
14. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.
1. Patients with R1 resection and with orthotropic neo-bladder reconstruction as urinary diversion are not eligible.
2. Patients with clinical or radiological evidence of metastases or N3 staged bladder cancer are not eligible.
3. 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),
4. Prior pelvic radiotherapy.
5. Patients with active inflammatory bowel disease.
6. Patients who required surgical treatment for bowel obstruction before bladder cancer diagnosis or after cystectomy.
7. Prior chemotherapy for other malignant diseases within the previous 5 years, except for neoadjuvant pre-cystectomy chemotherapy or adjuvant chemotherapy which are permitted.
8. 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.
9. Patients with any other disease or illness which requires hospitalization or is incompatible with the study treatment are not eligible.
10. 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.
11. Patients enrolled in another therapeutic study within 30 days prior of randomisation.
12. Person deprived of their liberty or under protective custody or guardianship.
18 Years
ALL
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Paul SARGOS, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Bergonié
Stéphane LARRE, Prof
Role: PRINCIPAL_INVESTIGATOR
CHU Robert Debré
Géraldine PIGNOT, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Paoli-Calmettes
Locations
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ICO Paul Papin
Angers, , France
Institut Bergonie
Bordeaux, , France
Centre Francois Baclesse
Caen, , France
Centre Georges-Francois Leclerc
Dijon, , France
Chu Grenoble
Grenoble, , France
Centre Oscar Lambret
Lille, , France
Hôpital Universitaire Dupuytren
Limoges, , France
Groupe Hospitalier Bretagne Sud
Lorient, , France
Centre Léon Bérard
Lyon, , France
CHU La Timone
Marseille, , France
Saint Louis
Paris, , France
Hopital Europeen Georges Pompidou
Paris, , France
Chp Saint-Gregoire
Saint-Grégoire, , France
ICO - site René Gauducheau
Saint-Herblain, , France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, , France
Institut Claudius Regaud
Toulouse, , France
Clinique Pasteur
Toulouse, , France
Countries
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Other Identifiers
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2016-A01535-46
Identifier Type: REGISTRY
Identifier Source: secondary_id
UC-0160/1617
Identifier Type: -
Identifier Source: org_study_id