Adjuvant Radiotherapy After Cystectomy for Muscle Invasive Bladder Cancer

Toxicity Clinical Trial

Official title:

Adjuvant Radiotherapy After Cystectomy for Patients With Muscle Invasive Bladder Cancer: a Phase II Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02397434
• Other study ID #: 2014/0630
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2014
• Est. completion date: October 30, 2028

Study information

• Verified date: October 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: October 30, 2028
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Toxicity
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Belgium	Dept of Radiotherapy, University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in acute Radiation Therapy Oncology Group (RTOG) toxicity		last day of radiotherapy, 1 month and 3 months after last day of EBRT
Secondary	change from baseline in late RTOG toxicity		at 6,9, 12, 18 and 24months after last day of EBRT
Secondary	change from baseline in local control		at 6,9, 12, 18 and 24months after last day of EBRT
Secondary	disease free survival		at 6,9, 12, 18 and 24months after last day of EBRT
Secondary	overall survival		at 6,9, 12, 18 and 24months after last day of EBRT