Cone-beam CT Guided Stereotactic Radiation Therapy for Locally Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Cone-beam CT Guided Stereotactic Radiation Therapy for Locally Advanced Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01898741
• Other study ID #: UMCU-12-628
• Status: Recruiting
• Phase: Phase 2
• First received: July 9, 2013
• Last updated: February 1, 2015
• Start date: July 2013
• Est. completion date: July 2016

Study information

• Verified date: February 2015
• Source: UMC Utrecht
• Contact: M. van Vulpen, Prof MD PhD
• Phone: +31 88 755 8800
• Email: m.vanvulpen[@]umcutrecht.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Radiation:
• 24 Gy in 3 fractions

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes