Skip to main content
OpenTrials
Completed

NCT Number: NCT01342354

Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer

This purpose of this study is to determine the highest tolerated dose of Stereotactic Body Radiation Therapy (SBRT) and also to determine the appropriate dose for intact pancreatic cancer.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must have histologically confirmed, unresected cancer of the pancreas or ampulla. The cancer may include any invasive histology (e.g. adenocarcinoma, neuroendocrine carcinoma).
  • Patients must have measurable radiographic disease.Patients with previous complete resection are only eligible if there is measurable radiographic disease which is clearly felt to represent locally recurrent disease.
  • Patients may receive any number of cycles of chemotherapy prior to treatment with SBRT, but not within 2 weeks of the first fraction of RT.
  • Age > or = 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 (Karnofsky > or = 60%)
  • Life expectancy of greater than 3 months.
  • Patients must have normal organ and marrow function.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

  • Concurrent investigational therapy delivered over the period of treatment or observation (28 days post-RT) for dose limiting toxicity.
  • Prior radiation therapy to the abdominal area which would overlap with the proposed area of treatment.
  • Pregnancy.
  • Primary disease > 7.5 cm in largest diameter as measured by CT or MRI.
  • Gross extension of tumor into the lumen of the duodenum.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Use of bevacizumab or vascular endothelial growth factor inhibitor chemotherapy within 3 months before RT or 6 months after RT.

Treatment and study plan

Stereotactic Radiation 10 Gy

Radiation

10 Gy three times over 10 days

Stereotactic Radiation 12.5 Gy

Radiation

12.5 Gy three times over 10 days

Stereotactic Radiation 15 Gy

Radiation

15 Gy three times over 10 days

Primary outcomes

  1. Maximum Tolerated Dose (Phase 1)

    Time frame: 28 days

    Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation.

Secondary outcomes

  1. The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity

    Time frame: 12 months after treatment

    Grade 3+ GI late toxicity

  2. Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale

    Time frame: 12 months after treatment

    Using the visual analog scale, patients rate pain from 1-10 with higher scores indicate greater pain intensity. Improvement in pain is defined as a yes/no response.

  3. Number of Patients Eligible for Surgery to Remove Tumor After Treatment

    Time frame: 12 months after treatment

  4. Number of Patients With Local Disease Control

    Time frame: 12 months after treatment

    Number of patients with no disease progression as measured by tumor imaging, based on RECIST criteria

  5. Change From Baseline in Patient Reported Outcomes Using FACT-Hepatobiliary (FACT-Hep) Quality of Life Questionnaire.

    Time frame: 12 months after treatment

    The Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) is an instrument that assesses health-related quality of life in patients with hepatobiliary cancers. The FACT-Hep consists of the FACT-G, which assesses generic health-related quality of life and concerns, and a validated Hepatobiliary Subscale (HS), which assesses disease-specific issues. Responses are on a 5 point Likert-type scale; items are summed to generate scores, with higher scores indicating better QOL (possible range of total score = 0-180).

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

A Study of Stereotactic Body Radiation Therapy in Patients With Unresected Carcinoma of the Pancreas or Ampulla

Important dates

Study start
2009
Primary completion
2020
Study completion
2022
First posted
Apr 27, 2011
Registry last updated
Jul 18, 2025

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.

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