Clinical trial NCT01898741: Cone-beam CT Guided Stereotactic Radiation Therapy for Locally Advanced Pancreatic Cancer
Official title: Cone-beam CT Guided Stereotactic Radiation Therapy for Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer
Radiotherapy
SBRT
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* WHO performance status 3-4
* Expected life span \<3 months
* Previous chemotherapy, pancreatic surgery or pancreatic radiotherapy
* Exclusion criteria for contrast enhanced MRI and/or CT scan, following the protocol of the department of radiology UMCU

Primary outcomes:
measure: Safety
timeFrame: 90 days of last irradiation
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: M. van Vulpen, Prof MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.