Cone-beam CT Guided Stereotactic Radiation Therapy for Locally Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01898741|
Recruitment Status : Unknown
Verified February 2015 by M. van Vulpen, UMC Utrecht.
Recruitment status was: Recruiting
First Posted : July 12, 2013
Last Update Posted : February 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Radiation: 24 Gy in 3 fractions||Phase 2|
Objective of the study:
To determine safety and technical feasibility of stereotactic radiotherapy for locally advanced pancreatic carcinoma
Pilot study to determine safety and feasibility
Patients with locally advanced pancreatic carcinoma, without distant metastasis
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cone-beam CT Guided Stereotactic Radiation Therapy for Locally Advanced Pancreatic Cancer|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||July 2016|
24 Gy in 3 fractions
Radiation: 24 Gy in 3 fractions
- Safety [ Time Frame: 90 days of last irradiation ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898741
|Contact: M. van Vulpen, Prof MD PhD||+31 88 755 email@example.com|
|University Medical Center Utrecht||Recruiting|
|Utrecht, Netherlands, 3584 CX|
|Contact: M. van Vulpen, Prof MD PhD +31 88 755 8800 firstname.lastname@example.org|
|Principal Investigator: M. van Vulpen, Prof MD PhD|
|Principal Investigator:||M. van Vulpen, Prof MD PhD||UMC Utrecht|