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2013-07
2016-07
2016-07
30
NCT01898741
UMC Utrecht
UMC Utrecht
INTERVENTIONAL
Cone-beam CT Guided Stereotactic Radiation Therapy for Locally Advanced Pancreatic Cancer
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.
Objective of the study: To determine safety and technical feasibility of stereotactic radiotherapy for locally advanced pancreatic carcinoma Study design: Pilot study to determine safety and feasibility Study population: Patients with locally advanced pancreatic carcinoma, without distant metastasis Intervention: Patients will undergo endoscopic fiducial marker placement, and patients will get a custom-made individual corset. Radiotherapy will be delivered in three fractions of 8 Gy on an outpatient basis. Primary study 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 radiation. Secondary study outcome: Other study parameters will be technical feasibility, treatment response, quality of life, overall survival, progression free survival, and rate of possible secondary resections Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2013-07-09 | N/A | 2015-02-01 |
2013-07-09 | N/A | 2015-02-03 |
2013-07-12 | N/A | 2015-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: irradiation 24 Gy in 3 fractions | RADIATION: 24 Gy in 3 fractions |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: M. van Vulpen, Prof MD PhD Phone Number: +31 88 755 8800 Email: m.vanvulpen@umcutrecht.nl |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
