Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer

• ClinicalTrials.gov Identifier: NCT01346410
• Recruitment Status: Completed
• First Posted: May 3, 2011
• Results First Posted: February 21, 2018
• Last Update Posted: February 21, 2018
• Sponsor: Mercy Research
• Information provided by (Responsible Party): Kathy Baglan, MD, Mercy Research

Tracking Information

• First Submitted Date: April 29, 2011
• First Posted Date: May 3, 2011
• Results First Submitted Date: January 24, 2018
• Results First Posted Date: February 21, 2018
• Last Update Posted Date: February 21, 2018
• Study Start Date: September 2008
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 14, 2016)

Local Control Rate [ Time Frame: 5 years ]

Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of > 20% in tumor size. If necessary, a Positron Emission Tomography scan may be used to aid in diagnoses of local tumor recurrence.

Original Primary Outcome Measures (submitted: April 29, 2011)

Local Control Rate [ Time Frame: 5 years ]

Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of > 20% in tumor size. If necessary, a PET/CT scan may be used to aid in diagnoses of local tumor recurrence.

• Change History: Complete list of historical versions of study NCT01346410 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: April 14, 2016)

Late Toxicity Rate [ Time Frame: 5 years ]

Toxicities will be graded using CTCAE criteria at specified timepoints.

Original Secondary Outcome Measures (submitted: April 29, 2011)

Late Toxicity Rate [ Time Frame: 5 years ]

Toxicities will be graded using CTCAE criteria at specifiec timepoints.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer
• Official Title: Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Unresectable Pancreatic Cancer
• Brief Summary: This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of unresectable pancreatic cancer.

Detailed Description

This is a single institution, non-randomized, prospective, phase IV trial of SBRT for unresectable pancreatic cancer.

Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities.

Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pancreatic Cancer

Intervention

Radiation: Stereotactic Body Radiotherapy

Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)

Study Arms

Experimental: A

Stereotactic Radiation to Pancreas

Intervention: Radiation: Stereotactic Body Radiotherapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 30, 2012): 1
• Original Estimated Enrollment (submitted: April 29, 2011): 20
• Actual Study Completion Date: July 2012
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patient age >= 18 years
• Performance status of 0-3
• Unresectable pancreatic cancer
• Maximum tumor diameter < 7.5 cm
• Signed study-specific consent form

Exclusion Criteria:

• Maximum tumor diameter > 7.5 cm
• Prior radiotherapy to the upper abdomen
• Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
• Patients with psychiatric or addictive disorder that would preclude obtaining informed consent

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01346410
• Other Study ID Numbers: 08-060
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Kathy Baglan, MD, Mercy Research
• Study Sponsor: Mercy Research
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Mercy Research
• Verification Date: February 2018