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Trial record 1 of 1 for:    NCT02397434
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Adjuvant Radiotherapy After Cystectomy for Muscle Invasive Bladder Cancer

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ClinicalTrials.gov Identifier: NCT02397434
Recruitment Status : Recruiting
First Posted : March 25, 2015
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
Radiotherapie, University Hospital, Ghent

Tracking Information
First Submitted Date  ICMJE November 19, 2014
First Posted Date  ICMJE March 25, 2015
Last Update Posted Date April 18, 2016
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2015)
change from baseline in acute Radiation Therapy Oncology Group (RTOG) toxicity [ Time Frame: last day of radiotherapy, 1 month and 3 months after last day of EBRT ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02397434 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2015)
  • change from baseline in late RTOG toxicity [ Time Frame: at 6,9, 12, 18 and 24months after last day of EBRT ]
  • change from baseline in local control [ Time Frame: at 6,9, 12, 18 and 24months after last day of EBRT ]
  • disease free survival [ Time Frame: at 6,9, 12, 18 and 24months after last day of EBRT ]
  • overall survival [ Time Frame: at 6,9, 12, 18 and 24months after last day of EBRT ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjuvant Radiotherapy After Cystectomy for Muscle Invasive Bladder Cancer
Official Title  ICMJE Adjuvant Radiotherapy After Cystectomy for Patients With Muscle Invasive Bladder Cancer: a Phase II Trial.
Brief Summary A radical cystectomy + extended pelvic lymph node dissection is considered to be the treatment of choice for patients with muscle invasive bladder cancer (MIBC). Despite this aggressive treatment the outcome is poor and ultimately, 30% of the patients with ≥pT3 tumors develop a pelvic recurrence. One- and 2-years survival for patients developing a local recurrence after cystectomy is only 8% and 3% respectively, with a median survival of <4 months. For patients with lymph node recurrence prognosis is somewhat better, but nevertheless still disappointing with reported 1- and 2 years survival of 42% and 11% respectively. The investigators hypothesize that an earlier implementation of external beam radiotherapy (EBRT) i.e. in the adjuvant setting, will prevent local and lymph node recurrence and improve disease free- and overall survival as local recurrence is linked to the development of distant metastasis. Adjuvant EBRT was tested in a prospective randomized trial and resulted in a 20% increase in 5-year disease free survival. Despite those impressive results, severe intestinal toxicity rates hampered the enthusiasm to use adjuvant EBRT, till now. In the last decade, great technological advancements in EBRT planning, such as intensity modulated arc therapy (IMAT), and positioning have been realised. This has resulted in a better coverage of the target volume while sparing normal tissue (mainly small bowel) and in a more precise delivery of the EBRT. Therefore, it is desirable to reconsider the use of adjuvant EBRT in selected MIBC patients.
Detailed Description

The investigators plan to perform a prospective phase 2 study including 76 patients.

Radiation up to a median dose of 50 Gy in 25 fractions will be delivered with IMAT to the pelvic lymph node regions. If there is a positive surgical margin, the operative bladder bed will be included in the radiation field. A simultaneous integrated boost to 64 Gy to the positive lymph nodes will be delivered. Pathological evaluation on cystectomy specimen includes: tumor stage and grade, area of necrosis (absolute and relative), micro vessel density, epidermal growth factor receptor.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Toxicity
Intervention  ICMJE Radiation: Adjuvant EBRT
Radiation up to a median dose of 50 Gy in 25 fractions will be delivered with IMAT to the pelvic lymph node regions. If there is a positive surgical margin, the operative bladder bed will be included in the radiation field. A simultaneous integrated boost to positive lymph nodes will be delivered.
Study Arms  ICMJE Experimental: Adjuvant EBRT
Radiation up to a median dose of 50 Gy in 25 fractions will be delivered with IMAT to the pelvic lymph node regions. If there is a positive surgical margin, the operative bladder bed will be included in the radiation field. A simultaneous integrated boost to positive lymph nodes will be delivered.
Intervention: Radiation: Adjuvant EBRT
Publications * Fonteyne V, Dirix P, Junius S, Rammant E, Ost P, De Meerleer G, Swimberghe M, Decaestecker K. Adjuvant radiotherapy after radical cystectomy for patients with muscle invasive bladder cancer: a phase II trial. BMC Cancer. 2017 May 2;17(1):308. doi: 10.1186/s12885-017-3302-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 24, 2015)
76
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: muscle invasive bladder cancer with:

  • ≥ pathological tumor stage (p)T3 stage + presence of lymphovascular invasion on pathological examination
  • pT4
  • <10 lymph nodes removed
  • positive lymph nodes
  • positive surgical margins

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Valérie Fonteyne, MD, PhD valerie.fonteyne@uzgent.be
Contact: Valérie Fonteyne, MD, PhD
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02397434
Other Study ID Numbers  ICMJE 2014/0630
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radiotherapie, University Hospital, Ghent
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Valérie Fonteyne University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP