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Adaptive Radiotherapy Using Plan Selection for Bladder Cancer

Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adverse Effects for Adaptive RT of Bladder Cancer

Intervention: Adaptive Radiotherapy (Radiation)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Aarhus

Official(s) and/or principal investigator(s):
Morten Høyer, MD, Professor, Principal Investigator, Affiliation: Aarhus University Hospital

Overall contact:
Morten Høyer, MD, PhD, Prof., Phone: +45 7846 2529, Email: hoyer@aarhus.rm.dk

Summary

This protocol describes a Phase 2 clinical trial of online adaptive Radiotherapy, using a library of 3 dose plans corresponding to Small, Medium and Large size bladder. The procedure includes 'Common Toxicity Criteria for Adverse Effects'(CTCAE) for registration of adverse effects (baseline, every 2'nd week during RT, 2 weeks, 3, 6, 12 and 24 month after RT) as well as cineMR for intra-fractional motion (baseline and every week during RT). Patients receive standard non-adaptive RT in the first week. Delineations of the bladder on the Cone-Beam scans (CBCT) from first week of treatment are used for planning the Small and Medium size bladder plans. Large size plan are the standard non-adaptive treatment plan used for the first week of treatment. A margin of 5 mm for intra fractional movement is used.

Clinical Details

Official title: Adaptive Radiotherapy Using Plan Selection for Bladder Cancer: A Phase II Trial

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Gastro- Intestinal toxicity

Secondary outcome:

Intra-fractional changes of bladder shape and size

Difference in accumulated dose to normal tissue

1 or 2 years disease free survival

Detailed description: After inclusion patients are asked about their adverse effects by an oncologist using CTCAE (version 4. 0) questionnaire. A planning CT-scan is acquired and for the first 10 patients also a MR-scan for intra fractional motion is acquired. The MR sequence is repeated every week during radiotherapy. The first week of treatment a standard non-adaptive IMRT-plan is used and CBCT-scans are acquired before and after treatment. The CBCT-scans are used for delineation of the bladder on the CBCT-scans from the first 4 fractions. The adaptive plans are generated from the union of the first 4 CBCT-bladders and the planning CT bladder (medium size) and the volume contained in at least 2 out of the 5 bladder volumes (small size). Details can be found in the reference list. From the 6'Th fraction the treatment is performed using the most appropriate size of treatment plan. CTCAE is repeated every other week during radiotherapy and 2 weeks, 3, 6, 12 and 24 month after radiotherapy.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Histologically proven bladder cancer

- Age over 18 years

- Urothelial or planocellular carcinoma

- Stage T2 T4A

- Stage N0M0

- Suitable for radiotherapy

- ECOG/WHO performance status 0-2

Exclusion Criteria:

- Suspected or confirmed distant metastases

- Previous surgery in the small pelvis

- Inflammatory bowel disease

Locations and Contacts

Morten Høyer, MD, PhD, Prof., Phone: +45 7846 2529, Email: hoyer@aarhus.rm.dk

Department of Oncology, Aarhus University Hospital, Aarhus 8000 C, Denmark; Recruiting
Morten Høyer, MD, PhD, Prof., Phone: +45 7846 2529, Email: hoyer@aarhus.rm.dk
Anne Vestergaard, MSc., Phone: +45 7846 2572, Email: annveste@rm.dk
Morten Høyer, MD, PhD, Prof., Principal Investigator

Herlev Hospital, Herlev 2730, Denmark; Not yet recruiting
Henriette Lindberg, MD, PhD, Phone: +4538689597, Email: Henriette.Lindberg@regionh.dk
Henriette Lindberg, MD, PhD, Principal Investigator

Additional Information

Protocol in Danish

Related publications:

Vestergaard A, Søndergaard J, Petersen JB, Høyer M, Muren LP. A comparison of three different adaptive strategies in image-guided radiotherapy of bladder cancer. Acta Oncol. 2010 Oct;49(7):1069-76. doi: 10.3109/0284186X.2010.501813.

Starting date: October 2012
Last updated: January 7, 2013

Page last updated: August 23, 2015

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