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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
Sponsor:
Information provided by (Responsible Party):
M. van Vulpen, UMC Utrecht

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: 24 Gy in 3 fractions Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: irradiation
24 Gy in 3 fractions
Radiation: 24 Gy in 3 fractions



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: M. van Vulpen, Prof MD PhD +31 88 755 8800 m.vanvulpen@umcutrecht.nl

Locations
Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: M. van Vulpen, Prof MD PhD    +31 88 755 8800    m.vanvulpen@umcutrecht.nl   
Principal Investigator: M. van Vulpen, Prof MD PhD         
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: M. van Vulpen, Prof MD PhD UMC Utrecht

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M. van Vulpen, Professor, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01898741     History of Changes
Other Study ID Numbers: UMCU-12-628
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: February 2015

Keywords provided by M. van Vulpen, UMC Utrecht:
Pancreatic cancer
Radiotherapy
SBRT

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases