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

NCT02347618 | Completed DMC

• 1 other identifier: UGIP14107
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence of grade 2 or greater toxicity

  Number of incidence of grade 2 or greater toxicity

  2 years

Secondary Outcomes (4)

• Number of Participants with no further growth of cancer at original site (Local control)

  2 years

• Count subjects with Recurrence of cancer in other body sites

  2 years

• Time to Progression of pancreatic cancer

  4 years

• Time to death

  4 years

Study Arms (1)

Preoperative SBRT

EXPERIMENTAL

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

Interventions

Preoperative SBRT RADIATION

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.

Preoperative SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Alan W Katz, MD MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 24, 2014
• First Posted: January 27, 2015
• Study Start: December 1, 2014
• Primary Completion: April 13, 2022
• Study Completion: April 13, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

US (1)