Neoadjuvant Stereotactic Body Radiation Therapy for Resectable Adenocarcinoma of the Pancreatic Head and/or Body

NCT02208024 | Completed Results DMC

• 1 other identifier: UCCI-GI-002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the safety of focused radiation (Stereotactic Body Radiation Therapy, SBRT) on patients with pancreatic cancer that will be removed surgically.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Acute (Within 3 Months of Treatment) Grade 3 or Greater Gastrointestinal Toxicity

  AEs were reviewed for gastrointestinal toxicity. Toxicities of note include grade 3 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity.

  3 months

Secondary Outcomes (4)

• Number of Participants With Late (Greater Than 3 Months After Treatment) Grade 2 Gastritis, Enteritis, Fistula, and Ulcer or Any Other Grade 3 or Greater Gastrointestinal Toxicity

  1 year

• Local Progression Free Survival

  1 year

• Metastasis Free Survival

  1 year

• Overall Survival

  1 year

Study Arms (1)

Stereotactic Body Radiation Therapy

EXPERIMENTAL

5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days

Radiation: Stereotactic Body Radiation Therapy

Interventions

Stereotactic Body Radiation Therapy RADIATION

Also known as: SBRT

Stereotactic Body Radiation Therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years.
• Histologically confirmed pancreatic adenocarcinoma of the head and/or body; at least the majority of the histopathologic specimen must be identified as adenocarcinoma.
• Pancreatic tumors must be considered resectable at time of treatment planning. Definition of resectable: no metastases, less than 180 degree involvement of superior mesenteric vein or portal vein, no involvement of hepatic artery, superior mesenteric artery or celiac artery
• No active infection requiring hospitalization
• Adequate labs
• Life expectancy \> 3 months.
• Patient is to have received chemotherapy prior to enrollment. This will typically consist of 3-4 cycles of chemotherapy. Patients will have a 2 week break between last chemotherapy administration and start of SBRT.

You may not qualify if:

• Presence of metastatic disease.
• Infections requiring systemic antibiotic treatment.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Jordan Kharofa, Associate Professor, Department of Radiation Oncology
• Organization: University of Cincinnati Cancer Center

kharofjr@ucmail.uc.edu

(513)-584-4073

Study Officials

• Michelle Mierzwa, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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: Assistant Professor Radiation Oncology

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 4, 2014
• Study Start: August 27, 2014
• Primary Completion: October 11, 2017
• Study Completion: May 12, 2019
• Last Updated: April 29, 2022
• Results First Posted: December 29, 2021

Record last verified: 2022-03

Locations

US (1)