Adjuvant Radiotherapy After Cystectomy for Muscle Invasive Bladder Cancer

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02397434
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Arm: 1
• Duration (Months): 72
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 76 participants
• Allocation: N/A
• 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: Oct 1, 2014
• Anticipated Primary Completion Date: Oct 1, 2018
• Anticipated Study Completion Date: Oct 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. change from baseline in late RTOG toxicity [at 6,9, 12, 18 and 24months after last day of EBRT]

2. change from baseline in local control [at 6,9, 12, 18 and 24months after last day of EBRT]

3. disease free survival [at 6,9, 12, 18 and 24months after last day of EBRT]

4. overall survival [at 6,9, 12, 18 and 24months after last day of EBRT]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept of Radiotherapy, University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

• Principal Investigator: Valérie Fonteyne, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Radiotherapie, Valérie Fonteyne MD, PhD, University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT02397434
• Other Study ID Numbers: 2014/0630
• First Posted: Mar 25, 2015
• Last Update Posted: Apr 18, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Radiotherapie, Valérie Fonteyne MD, PhD, University Hospital, Ghent: assessment of QOL (EORTC QLQ-C30)
• Additional relevant MeSH terms: Urinary Bladder Neoplasms

Study Results

No Results Posted as of Apr 18, 2016