To determine safety and technical feasibility of stereotactic radiotherapy for locally advanced and locally recurrent pancreatic carcinoma.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Hepatobiliary neoplasms malignant and unspecified
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint will be 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 irradiation.
Secondary outcome
Other study parameters will be technical feasibility, treatment response,
quality of life, overall survival, progression free survival, and rate of
possible secondary resections.
Background 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 and locally recurrent
pancreatic carcinoma.
Study objective
To determine safety and technical feasibility of stereotactic radiotherapy for
locally advanced and locally recurrent pancreatic carcinoma.
Study design
Pilotstudy to determine safety and feasibility.
Intervention
Pre-treatment, (recurrent) pancreatic cancer has to be pathology proven.
Patients will undergo a contrast-enhanced CT scan, a contrast-enhanced MRI
scan, endoscopic fiducial placement, and patients will get a custom-made
individual corset. Baseline toxicity and quality of life will be assessed.
Radiotherapy will be delivered in three fractions on an outpatient basis. After
treatment, follow-up will be at 1, 3, 6, and 12 months. Toxicity and quality of
life will be assessed during these outpatient department visits. A CT scan and
an MRI scan will be performed 3 months after treatment to assess treatment
response.
Study burden and risks
Increased severe toxicity may occur due to the intervention, but treatment
related toxicity should be limited due to strict dose constraints to the organs
at risk (e.g. duodenum, stomach). Potential benefits may be pain relief, due to
local control of the tumor, and a prolonged survival.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
* Pancreatic cancer:
- Primary unresectable pancreatic tumors according to Dutch Pancreatic Cancer Group; or
- Medically inoperable patients with pancreatic cancer; or
- Isolated locally recurrent pancreatic cancer.
* *18 years.
* Written informed consent.
Exclusion criteria
* Evidence of distant metastasis.
* WHO performance status 3-4.
* Expected life span <3 months.
* Exclusion criteria for contrast enhanced MRI and/or CT scan, following the protocol of the department of radiology UMCU.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01898741 |
| CCMO | NL42053.041.12 |