Cone-beam CT Guided Stereotactic Radiation Therapy for Locally Advanced Pancreatic Cancer
1 other identifier
interventional
30
1 country
1
Brief Summary
Pancreatic cancer has a very poor survival, due to late diagnosis and lack of sufficient treatment options for locally advanced tumors and metastasized patients. High dose radiotherapy with small margins seems feasible with current technical possibilities, e.g. by fiducial guided stereotactic radiotherapy. In this study, we want to evaluate safety and technical feasibility for cone beam CT guided stereotactic radiotherapy for locally advanced pancreatic carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 pancreatic-cancer
Started Jul 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 9, 2013
CompletedFirst Posted
Study publicly available on registry
July 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedFebruary 3, 2015
February 1, 2015
3 years
July 9, 2013
February 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
Safety of the procedure, expressed in proportion of patients experiencing treatment-induced toxicity grade 3 or more according to the CTC-AE 4.0 due to the complete procedure within 90 days of the last radiation
90 days of last irradiation
Study Arms (1)
irradiation
EXPERIMENTAL24 Gy in 3 fractions
Interventions
Eligibility Criteria
You may qualify if:
- Locally advanced pancreatic tumors (stage III) or medically inoperable patients with pancreatic cancer (stage I, II, or III)
- Not eligible for operation with curative intent
- \>18 years
- Written informed consent
You may not qualify if:
- WHO performance status 3-4
- Expected life span \<3 months
- Previous chemotherapy, pancreatic surgery or pancreatic radiotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
Study Sites (1)
University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX, Netherlands
Related Publications (1)
Heerkens HD, van Vulpen M, Erickson B, Reerink O, Intven MP, van den Berg CA, Molenaar IQ, Vleggaar FP, Meijer GJ. MRI guided stereotactic radiotherapy for locally advanced pancreatic cancer. Br J Radiol. 2018 Nov;91(1091):20170563. doi: 10.1259/bjr.20170563. Epub 2018 Jul 31.
PMID: 30063383DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
M. van Vulpen, Prof MD PhD
UMC Utrecht
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 9, 2013
First Posted
July 12, 2013
Study Start
July 1, 2013
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
February 3, 2015
Record last verified: 2015-02