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Completed

NCT Number: NCT00350142

Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer

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

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

In this study, we propose to combine stereotactic body radiotherapy (SBRT) with standard gemcitabine chemotherapy. We hypothesize that earlier administration of systemic chemotherapy may prolong the interval to distant progression and improve overall survival in these patients. In this study, we will treat pancreatic cancer patients with locally advanced disease with 3 weeks of gemcitabine, followed by Trilogy(TM) SBRT and additional gemcitabine. 30 patients will be accrued to this study at Stanford University Medical Center, the only site participating in this research study. Treatment on this protocol requires placement of 3-5 gold (99.9% pure) fiducials for targeting purposes. Four to 7 days after placement of the fiducials, patients will then undergo a 4D pancreatic protocol CT scan through the upper abdomen. In addition, an FDG PET scan is required for treatment planning purposes. This imaging set will be processed for radiosurgery, using a modified linac based radiation treatment planning system (EclipseTM). An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy prescribed to the isodose line that completely surrounds the gross pancreatic tumor volume (GTV) as defined by the contrast CT. Following SBRT, patients will be monitored clinically and radiographically.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

stereotactic body radiotherapy

Radiation

Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator

Other names: single fraction 25 Gy dose Stereotactic Body Radiotherapy

Gemcitabine

Drug

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

Other names: Gemzar

4D pancreatic protocol CT scan

Other

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

Other names: computerized tomography scan

FDG PET scan

Radiation

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

Other names: Fluorodeoxyglucose (FDG)-positron emission tomography

Primary outcomes

  1. Rate of Local Control

    Time frame: up to 3 years

    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.

Secondary outcomes

  1. Median Overall Survival Time

    Time frame: up to 3 years

    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.

Sponsors and collaborators

Lead sponsor

Albert Koong

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 10, 2006
Registry last updated
Feb 14, 2017

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.

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