Adjuvant Radiotherapy After Cystectomy for Muscle Invasive Bladder Cancer

NCT02397434 | Active Not Recruiting

• 1 other identifier: 2014/0630
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Toxicity

Keywords

assessment of QOL (EORTC QLQ-C30)

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• change from baseline in late RTOG toxicity

  at 6,9, 12, 18 and 24months after last day of EBRT

• change from baseline in local control

  at 6,9, 12, 18 and 24months after last day of EBRT

• disease free survival

  at 6,9, 12, 18 and 24months after last day of EBRT

• overall survival

  at 6,9, 12, 18 and 24months after last day of EBRT

Study Arms (1)

Adjuvant EBRT

EXPERIMENTAL

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

Interventions

Adjuvant EBRT RADIATION

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.

Adjuvant EBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Dept of Radiotherapy, University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 28464906 DERIVED

Study Officials

• Valérie Fonteyne

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: March 25, 2015
• Study Start: October 1, 2014
• Primary Completion: October 30, 2018
• Study Completion (Estimated): October 30, 2028
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

BE (1)