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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03333356
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
UNICANCER

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.


Condition or disease Intervention/treatment Phase
Patients With High-risk MIBC Radiation: pelvic radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Adjuvant Radiotherapy in Patients With Pathological High-risk Bladder Cancer: A Randomized Multicentre Phase II Study
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: 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).
Radiation: 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).

No Intervention: Standard Arm
Surveillance



Primary Outcome Measures :
  1. pelvic recurrence-free survival (PRFS) [ Time Frame: 3 years ]
    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.


Secondary Outcome Measures :
  1. pelvic recurrence-free survival (PRFS) [ Time Frame: 5 years ]
    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.

  2. Disease-free survival (DFS) [ Time Frame: 3 years ]
    DFS is defined as the delay between randomization and tumor progression (local, regional, or distant) or death of any cause, whichever occurs first.

  3. Disease-free survival (DFS) [ Time Frame: 5 years ]
    DFS is defined as the delay between randomization and tumor progression (local, regional, or distant) or death of any cause, whichever occurs first.

  4. Overall Survival (OS) [ Time Frame: 3 years ]
    OS is defined as the delay between randomization and death, of any cause.

  5. Overall Survival (OS) [ Time Frame: 5 years ]
    OS is defined as the delay between randomization and death, of any cause.

  6. Metastasis-free survival (MFS) [ Time Frame: 3 years ]
    MFS is defined as the delay between randomization, and metastasis (clinical or radiological) or death of any cause whichever occurs first.

  7. Metastasis-free survival (MFS) [ Time Frame: 5 years ]
    MFS is defined as the delay between randomization, and metastasis (clinical or radiological) or death of any cause whichever occurs first.

  8. Disease-specific survival (DSS) [ Time Frame: 3 years ]
    DSS is defined as the delay between randomization and death due to bladder cancer.

  9. Disease-specific survival (DSS) [ Time Frame: 5 years ]
    DSS is defined as the delay between randomization and death due to bladder cancer.

  10. Tolerance will be evaluated by toxicity: acute (<6 months after RT) and late (≥6 months after RT), assessed using the NCI CTCAE Version N°4.0 [ Time Frame: 5 years ]
    The tolerance will be evaluated by toxicity: acute (<6 months after RT) and late (≥6 months after RT), assessed using the NCI CTCAE Version N°4.0.

  11. Patients' quality of Life [ Time Frame: 5 years ]
    EORTC QLQ-C30

  12. Patient quality of Life [ Time Frame: 5 years ]
    The Bladder Cancer Index (BCI)

  13. Evaluation of acute and late toxicities [ Time Frame: 5 years ]
    The safety will be evaluated by toxicity: acute (<6 months after RT) and late (≥6 months after RT), assessed using the NCI CTCAE Version N°4.0.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be eligible, the patients must fulfil all of the following inclusion criteria:

  1. 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.
  2. Patients with radical cystectomy and pelvic lymph nodes dissection with no macroscopic 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 are eligible.
  4. Patients having received neo-adjuvant or adjuvant chemotherapy treatment are eligible. Randomisation is allowed only if AE due to chemotherapy are ≤grade 2.
  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 (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) ≤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 of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 6 months after the adjuvant radiotherapy. Acceptable method of contraception includes: hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal associated with inhibition of ovulation (oral, intravaginal, transdermal), intrauterine devices, sexual abstinence, bilateral tubal ligation, vasectomy, for female: partner who have had a vasectomy, for male: partner who is not of childbearing potential. Women must have a negative urine or serum pregnancy test within 14 days prior to randomization.
  13. Patients having provided written informed consent prior to any study-related procedures.
  14. Patients affiliated to the social security scheme.
  15. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.

Exclusion Criteria:

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

  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 (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]), unless disease free for a minimum of three years prior to inclusion.
  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, except for neoadjuvant pre-cystectomy chemotherapy which is 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 randomization.
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of inclusion.
    • 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. Pregnant or breast feeding mothers.
  13. Person deprived of their liberty or under protective custody or guardianship.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333356


Contacts
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Contact: Sandra PELISSIER + 33 1 44 23 55 68 s-pelissier@unicancer.fr

Locations
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France
Clinique de L'Europe Not yet recruiting
Amiens, France, 80090
Contact: Michel GOZY, MD    +33 3 60 12 76 78    michelgozy@gmail.com   
Clinique Générale d'Annecy Recruiting
Annecy, France, 74000
Contact: Anne DONEUX, MD    +33 4 50 63 69 89    adoneux@ch-annecygenevois.fr   
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Paul SARGOS, MD    + 33 5 56 33 33 76    P.Sargos@bordeaux.unicancer.fr   
Clinique Pasteur Cfro Recruiting
Brest, France, 29200
Contact: Ali HASBINI, MD    +33 2 98 31 32 00    alihasbini@oncologie-brest.fr   
Hopital Henri Mondor Not yet recruiting
Créteil, France, 94000
Contact: Yazid BELKACEMI, Prof    +33 1 49 81 45 22    yazid.belkacemi@hmn.aphp.fr   
Centre Georges-Francois Leclerc Recruiting
Dijon, France, 21079
Contact: Etienne MARTIN, MD    +33 3 80 73 75 18    emartin@cgfl.fr   
Chu Grenoble Recruiting
Grenoble, France, 38043
Contact: Olivier VERRY, MD    +33 4 76 76 54 35    cverry@chu-grenoble.fr   
Centre Oscar Lambret Not yet recruiting
Lille, France, 59000
Contact: David PASQUIER, MD    +33 3 20 29 51 44    d-pasquier@o-lambret.fr   
Hôpital Universitaire Dupuytren Recruiting
Limoges, France, 87042
Contact: Pierre CLAVERE, Prof    +33 5 55 05 62 69    pierre.clavere@chu-limoges.fr   
Centre Léon Bérard Recruiting
Lyon, France, 69008
Contact: Pascale POMMIER, MD    +33 4 78 78 51 66    pascal.pommier@lyon.unicancer.fr   
CHU La Timone Not yet recruiting
Marseille, France, 13385
Contact: Xavier MURACCIOLE, MD       xavier.muracciole@ap-hm.fr   
Institut Regional Du Cancer Montpellier Not yet recruiting
Montpellier, France, 34298
Contact: David AZRIA, Prof    +33 4 67 61 85 79    david.azria@icm.unicancer.fr   
Saint Louis Not yet recruiting
Paris, France, 75010
Contact: Christophe HENNEQUIN, Prof    +33 1 42 49 90 24    christophe.hennequin2@aphp.fr   
Hopital Europeen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Catherine DURDUX, Prof    +33 1 56 09 34 02    catherine.durdux@.aphp.fr   
Hu Pitie-Salpetriere Not yet recruiting
Paris, France, 75651
Contact: Jean-Marc SIMON, MD    +33 1 42 17 81 60    jean-marc.simon@aphp.fr   
CH Lyon Sud Not yet recruiting
Pierre-Bénite, France, 69310
Contact: Olivier CHAPET, Prof    +33 4 78 86 42 51    olivier.chapet@chu-lyon.fr   
Centre Eugene Marquis Suspended
Rennes, France, 35042
Chp Saint-Gregoire Recruiting
Saint Gregoire, France, 35760
Contact: Xavier ARTIGNAN    +33 2 90 09 44 64    xartignan@vivalto-sante.com   
ICO - site René Gauducheau Not yet recruiting
Saint-Herblain, France, 44805
Contact: Stéphane SUPIOT, MD    +33 2 40 67 99 13    stephane.supiot@ico.unicacner.fr   
Institut de Cancérologie Lucien Neuwirth Recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Nicolas MAGNE, Prof    +33 4 77 91 71 04    nicolas.magne@icloire.fr   
Institut Claudius Regaud Recruiting
Toulouse, France, 31059
Contact: Pierre GRAFF-CAILLEAUD, MD    +33 5 31 15 54 30    graff-cailleaud.pierre@iuct-oncopole.fr   
Clinique Pasteur Recruiting
Toulouse, France, 31076
Contact: Igor LATORZEFF, MD    +33 5 67 20 44 00    i.latorzeff@clinique-pasteur.com   
Gustave Roussy Cancer Campus Grand Paris Suspended
Villejuif, France, 94805
Sponsors and Collaborators
UNICANCER
Investigators
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Principal Investigator: Paul SARGOS, MD Institut Bergonié
Principal Investigator: Stéphane LARRE, Prof CHU Robert Debré

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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT03333356     History of Changes
Other Study ID Numbers: UC-0160/1617
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases