Skip to main content
OpenTrials
Completed

NCT Number: NCT02208024

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stereotactic Body Radiation Therapy

Radiation

Other names: SBRT

Primary outcomes

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

    Time frame: 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 outcomes

  1. 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

    Time frame: 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.

  2. Local Progression Free Survival

    Time frame: 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.

  3. Metastasis Free Survival

    Time frame: 1 year

  4. Overall Survival

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

Phase I Study to Evaluate the Feasibility of Neoadjuvant Stereotactic Body Radiation Therapy for Resectable Adenocarcinoma of the Pancreatic Head and/or Body

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Aug 4, 2014
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.