Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Phase II Study to Evaluate the Efficacy of Trilogy Stereotactic Radiosurgery for Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350142
• Other study ID #: PANC0005
• Secondary ID: PANC0005
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2006
• Last updated: August 6, 2014
• Start date: April 2006
• Est. completion date: October 2008

Study information

• Verified date: August 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy of treating locally advanced pancreatic cancer using Stereotactic Body Radiotherapy (using Trilogy) and Gemcitabine

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:- Pancreatic tumors not to exceed 10 cm in greatest axial dimension

• Histologically confirmed malignancies of the pancreas

• Unresectable by CT criteria or exploratory laparotomy or laparoscopy

• Patients with metastatic disease may be treated if they are symptomatic from the primary tumor

• Performance status of 0, 1, or 2

• No chemotherapy two weeks prior or two weeks following radiosurgery

Exclusion Criteria:

• patients who have had prior radiotherapy to upper abdomen

• patients receiving any prior pancreatic cancer therapy

• children, pregnant, and breastfeeding women, and lab personnel are excluded

• uncontrolled intercurrent illnesses

• any concurrent malignancy

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Radiation:
• Stereotactic Body Radiotherapy
Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator

Drug:
• Gemcitabine
Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Albert Koong

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Local Control	The proportion of patients with local control where local control is defined as no recurrence or disease progression in the primary disease site.; Disease progression was defined using either the RECIST or Pet criteria. Using the RECIST criteria disease progression is defined as a more than 25% tumor increase by volume and/ or presence of a new lesion. Using the Pet criteria disease progression is defined as an increase in PET activity as compared to the scan used in the planning of the treatment; any subsequent increase in SUVmax was defined as local progression.	up to 3 years	No
Secondary	Median Overall Survival Time	The survival time for each patient is measured as the number of months from randomization until the time of death from any cause. The median survival time is computed using Kaplan Meier curves.	up to 3 years	No