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

Not Applicable

Completed

• Conditions: Pancreatic Cancer
• Interventions: Radiation: Stereotactic Body Radiation Therapy

• Registration Number: NCT02208024
• Lead Sponsor: University of Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-31
• Study First Submitted QC: 2014-07-31
• Study First Posted: 2014-08-04
• Study Start: 2014-08-27
• Primary Completion: 2017-10-11
• Study Completion: 2019-05-12
• Results First Submitted: 2021-12-02
• Results First Submitted QC: 2021-12-02
• Results First Posted: 2021-12-29
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic Body Radiation Therapy	Stereotactic Body Radiation Therapy	5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days

Primary Outcome Measures

Name	Time	Method
Number of Participants With Acute (Within 3 Months of Treatment) Grade 3 or Greater Gastrointestinal Toxicity	3 months	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.

Secondary Outcome Measures

Name	Time	Method
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	AEs were assessed for gastrointestinal toxicity. Toxicities of note include grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity.
Metastasis Free Survival	1 year
Overall Survival	1 year
Local Progression Free Survival	1 year	Local tumor progression will be defined as \>=20% increased size on CT scan compared to a CT. scan from prior to treatment. Distant progression will be defined as any new tumor found outside of the pancreas or periampullary region on CT scan. Local and/or distant progression will be evaluated by both PET/CT (if available) and CT scan as deemed by treating physician.

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States