Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer
Primary Purpose
Pancreatic Cancer, Adenocarcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preoperative SBRT
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Patient with pathologically proven diagnosis of adenocarcinoma of the head of the pancreas
- CT w/ contrast using the pancreas protocol or MRI of the abdomen with contrast within 6 weeks prior to registration
- CT chest or PET/CT within 6 weeks prior to registration
- Clinically determined to be resectable based on NCCN Criteria:
- No radiographic evidence of superior mesenteric vein or portal vein distortion
- No evidence of distant metastasis
- Clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery
- No enlarged lymph nodes per CT criteria or PET avid lymph nodes
- No lymphadenopathy outside the surgical field (i.e. celiac or para-aortic adenopathy)
- Adequate cardiopulmonary reserves to tolerate surgery
- Karnofsky performance status > 70
- Age >18
- Adequate bone marrow function defined as follows:
- Absolute neutrophil count (ANC) > 1800 cells/mm3
- Platelets ≥ 100,000 cells/mm3
- Hemoglobin > 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > 8 g/dl is acceptable.)
- Pregnancy test must be negative for women of childbearing potential within 7 days prior to study entry
- Patient must sign study specific informed consent prior to study entry
Exclusion Criteria:
- Prior surgical resection of any pancreatic malignancy
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
- Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Severe, active comorbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration.
- Severe, uncorrectable hepatic insufficiency and/or coagulation defects due to liver failure
- Any evidence of distant metastases (M1)
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Preoperative SBRT
Arm Description
This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.
Outcomes
Primary Outcome Measures
Incidence of grade 2 or greater toxicity
Number of incidence of grade 2 or greater toxicity
Secondary Outcome Measures
Number of Participants with no further growth of cancer at original site (Local control)
Count subjects with no further growth of cancer at original site.
Count subjects with Recurrence of cancer in other body sites
Compare recurrence locations of treated patients relative to historical controls.
Time to Progression of pancreatic cancer
Duration of progression free survival of treated patients
Time to death
Measure duration of survival of treated patients.
Full Information
NCT ID
NCT02347618
First Posted
December 24, 2014
Last Updated
July 15, 2022
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT02347618
Brief Title
Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer
Official Title
Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
April 13, 2022 (Actual)
Study Completion Date
April 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether a short-course of stereotactic body radiotherapy (SBRT) prior to surgical resection of pancreatic adenocarcinoma is feasible and well-tolerated.
Detailed Description
This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preoperative SBRT
Arm Type
Experimental
Arm Description
This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.
Intervention Type
Radiation
Intervention Name(s)
Preoperative SBRT
Intervention Description
This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.
Primary Outcome Measure Information:
Title
Incidence of grade 2 or greater toxicity
Description
Number of incidence of grade 2 or greater toxicity
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of Participants with no further growth of cancer at original site (Local control)
Description
Count subjects with no further growth of cancer at original site.
Time Frame
2 years
Title
Count subjects with Recurrence of cancer in other body sites
Description
Compare recurrence locations of treated patients relative to historical controls.
Time Frame
2 years
Title
Time to Progression of pancreatic cancer
Description
Duration of progression free survival of treated patients
Time Frame
4 years
Title
Time to death
Description
Measure duration of survival of treated patients.
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with pathologically proven diagnosis of adenocarcinoma of the head of the pancreas
CT w/ contrast using the pancreas protocol or MRI of the abdomen with contrast within 6 weeks prior to registration
CT chest or PET/CT within 6 weeks prior to registration
Clinically determined to be resectable based on NCCN Criteria:
No radiographic evidence of superior mesenteric vein or portal vein distortion
No evidence of distant metastasis
Clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery
No enlarged lymph nodes per CT criteria or PET avid lymph nodes
No lymphadenopathy outside the surgical field (i.e. celiac or para-aortic adenopathy)
Adequate cardiopulmonary reserves to tolerate surgery
Karnofsky performance status > 70
Age >18
Adequate bone marrow function defined as follows:
Absolute neutrophil count (ANC) > 1800 cells/mm3
Platelets ≥ 100,000 cells/mm3
Hemoglobin > 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > 8 g/dl is acceptable.)
Pregnancy test must be negative for women of childbearing potential within 7 days prior to study entry
Patient must sign study specific informed consent prior to study entry
Exclusion Criteria:
Prior surgical resection of any pancreatic malignancy
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor.
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Severe, active comorbidity, defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months
Transmural myocardial infarction within the last 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration.
Severe, uncorrectable hepatic insufficiency and/or coagulation defects due to liver failure
Any evidence of distant metastases (M1)
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan W Katz, MD MPH
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer
We'll reach out to this number within 24 hrs