Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer

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.

Study Overview

• Status: Completed
• Conditions: Adenocarcinoma; Pancreatic Cancer
• Intervention / Treatment: Radiation: Preoperative SBRT

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient with pathologically proven diagnosis of adenocarcinoma of the head of the pancreas
2. CT w/ contrast using the pancreas protocol or MRI of the abdomen with contrast within 6 weeks prior to registration
3. CT chest or PET/CT within 6 weeks prior to registration
4. Clinically determined to be resectable based on NCCN Criteria:
5. No radiographic evidence of superior mesenteric vein or portal vein distortion
6. No evidence of distant metastasis
7. Clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery
8. No enlarged lymph nodes per CT criteria or PET avid lymph nodes
9. No lymphadenopathy outside the surgical field (i.e. celiac or para-aortic adenopathy)
10. Adequate cardiopulmonary reserves to tolerate surgery
11. Karnofsky performance status > 70
12. Age >18
13. Adequate bone marrow function defined as follows:
14. Absolute neutrophil count (ANC) > 1800 cells/mm3
15. Platelets ≥ 100,000 cells/mm3
16. Hemoglobin > 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > 8 g/dl is acceptable.)
17. Pregnancy test must be negative for women of childbearing potential within 7 days prior to study entry
18. Patient must sign study specific informed consent prior to study entry

Exclusion Criteria:

1. Prior surgical resection of any pancreatic malignancy
2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
3. Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor.
4. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

5. Severe, active comorbidity, defined as follows:

   1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months
   2. Transmural myocardial infarction within the last 6 months
   3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
   4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration.
6. Severe, uncorrectable hepatic insufficiency and/or coagulation defects due to liver failure
7. Any evidence of distant metastases (M1)
8. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Preoperative SBRT; 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.	Radiation: Preoperative SBRT; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of grade 2 or greater toxicity	Number of incidence of grade 2 or greater toxicity	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years
Count subjects with Recurrence of cancer in other body sites	Compare recurrence locations of treated patients relative to historical controls.	2 years
Time to Progression of pancreatic cancer	Duration of progression free survival of treated patients	4 years
Time to death	Measure duration of survival of treated patients.	4 years

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Alan W Katz, MD MPH, University of Rochester

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ACTUAL): April 13, 2022
• Study Completion (ACTUAL): April 13, 2022

Study Registration Dates

• First Submitted: December 24, 2014
• First Submitted That Met QC Criteria: January 21, 2015
• First Posted (ESTIMATE): January 27, 2015

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: UGIP14107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No