Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer
This study is currently recruiting participants.
Verified September 2012 by University of Chicago
Sponsor:
University of Chicago
Information provided by (Responsible Party):
Stanley Liauw, University of Chicago
ClinicalTrials.gov Identifier:
NCT01342354
First received: April 15, 2011
Last updated: September 7, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Radiation: Stereotactic Radiation |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Stereotactic Body Radiation Therapy in Patients With Unresected Carcinoma of the Pancreas or Ampulla |
Resource links provided by NLM:
Further study details as provided by University of Chicago:
Primary Outcome Measures:
- Maximum Tolerated Dose [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation.
| Estimated Enrollment: | 24 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | April 2017 |
| Estimated Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Stereotactic Radiation
Escalating doses of SBRT in three doses over ten days.
|
Radiation: Stereotactic Radiation
Escalating Doses of SBRT in periods of three doses over 10 days
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342354
Locations
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Kimberly Janko, RN, BSN 773-702-2856 kjanko@radonc.uchicago.edu | |
Sponsors and Collaborators
University of Chicago
Investigators
| Principal Investigator: | Stanley Liauw, MD | University of Chicago |
More Information
No publications provided
| Responsible Party: | Stanley Liauw, Assistant Professor of Radiology, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT01342354 History of Changes |
| Other Study ID Numbers: | 16866B |
| Study First Received: | April 15, 2011 |
| Last Updated: | September 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Chicago:
|
Pancreatic Cancer Stereotactic Radiation |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013