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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

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.

Condition or disease Intervention/treatment Phase
Toxicity Radiation: Adjuvant EBRT Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Radiotherapy After Cystectomy for Patients With Muscle Invasive Bladder Cancer: a Phase II Trial.
Study Start Date : October 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. change from baseline in late RTOG toxicity [ Time Frame: at 6,9, 12, 18 and 24months after last day of EBRT ]
  2. change from baseline in local control [ Time Frame: at 6,9, 12, 18 and 24months after last day of EBRT ]
  3. disease free survival [ Time Frame: at 6,9, 12, 18 and 24months after last day of EBRT ]
  4. overall survival [ Time Frame: at 6,9, 12, 18 and 24months after last day of EBRT ]


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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: 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:

-


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): NCT02397434


Contacts
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Contact: Valérie Fonteyne, MD, PhD valerie.fonteyne@uzgent.be
Contact: Valérie Fonteyne, MD, PhD

Locations
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Belgium
Dept of Radiotherapy, University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Valérie Fonteyne, MD; PhD       valerie.fonteyne@uzgent.be   
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Valérie Fonteyne University Hospital, Ghent

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radiotherapie, Valérie Fonteyne MD, PhD, University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT02397434     History of Changes
Other Study ID Numbers: 2014/0630
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016

Keywords provided by Radiotherapie, University Hospital, Ghent:
assessment of QOL (EORTC QLQ-C30)

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases