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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01342354
• Other study ID #: 16866B
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: April 14, 2009
• Est. completion date: June 1, 2022

Study information

• Verified date: March 2021
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. completion date: June 1, 2022
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Radiation:
• Stereotactic Radiation
Escalating Doses of SBRT in periods of three doses over 10 days

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (phase 1)	Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation.	28 days
Primary	Identify the appropriate dose for treatment of unresected carcinoma of the ampulla or pancreas		28 days
Secondary	Reported side effects		12 months after treatment
Secondary	Change in patient reported pain score using visual analog scale	Using the visual analog scale, patients rate pain from 1-10 with higher scores indicate greater pain intensity.	12 months after treatment
Secondary	Number of patients eligible for surgery to remove tumor after treatment		12 months after treatment
Secondary	Number of patients with disease control	Number of patients with no disease progression as measured by tumor imaging	12 months after treatment
Secondary	Change in patient reported outcomes using FACT-Hepatobiliary (FACT-Hep) quality of life questionnaire.		12 months after treatment