Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer

NCT00350142 | Completed Phase 2 Results DMC

• 1 other identifier: PANC0005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer

Keywords

Stereotactic Body Radiotherapy (SBRT); pancreas cancer; locally advanced; local control; Gemcitabine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Median Overall Survival Time

  up to 3 years

Study Arms (1)

Stereotactic Body Radiotherapy

EXPERIMENTAL

Patients will have a 4D pancreatic protocol CT and a FDG PET scan scan, both for planning purposes. An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy dose of Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine.

Radiation: Stereotactic Body Radiotherapy; Drug: Gemcitabine; Other: 4D pancreatic protocol CT scan; Radiation: FDG PET scan

Interventions

Stereotactic Body Radiotherapy RADIATION

Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator

Also known as: single fraction 25 Gy dose Stereotactic Body Radiotherapy

Stereotactic Body Radiotherapy

Gemcitabine DRUG

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

Also known as: Gemzar

Stereotactic Body Radiotherapy

4D pancreatic protocol CT scan OTHER

Patients will undergo this imaging procedure prior to treatment for planning purposes.

Also known as: computerized tomography scan

Stereotactic Body Radiotherapy

FDG PET scan RADIATION

Patients will have this imaging procedure along with a CT scan to map the tumor and facilitate treatment planning.

Also known as: Fluorodeoxyglucose (FDG)-positron emission tomography

Stereotactic Body Radiotherapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Koong: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiosurgery; Gemcitabine; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyglucose; Deoxy Sugars; Carbohydrates

Results Point of Contact

• Title: Dr. Albert Koong
• Organization: Stanford Cancer Center

akoong@stanford.edu

650-498-7703

Study Officials

• Albert Koong

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Radiation Oncology

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 10, 2006
• Study Start: April 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: February 14, 2017
• Results First Posted: August 22, 2014

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)