Skip to main content
OpenTrials
Completed

NCT Number: NCT01051284

A Study of Gemcitabine and Cyberknife Radiation Therapy for Pancreatic Cancer

People with pancreatic cancer that cannot be cured by surgery are being asked to participate in this study.

The purpose of this study is to test the ability of the radiation oncologists to administer Cyberknife therapy along with Gemcitabine chemotherapy for patients with pancreatic cancer. Radiation and Gemcitabine are both effective at killing cancer cells but they generally cannot be given at the same time. Cyberknife therapy is highly focused radiation that is being used extensively at Georgetown University and around the United States to treat a number of cancers. It is believed that because Cyberknife is so highly focused it can be given safely with regular doses of chemotherapy to attack cancer cells in two ways at the same time.

This research is being done because it is not known if using Cyberknife with chemotherapy will be a safe way to treat pancreatic cancer.

Completed

Looking for future studies?

Notify Me

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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

About this study

This is a single arm, open-label pilot study of Cyberknife plus Gemcitabine in 10 patients with locally advanced pancreatic cancer who have not received prior local or systemic therapy for their pancreatic cancer.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically proven unresectable, non-metastatic pancreatic adenocarcinoma with measurable or evaluable disease and without involvement of the duodenum
  • Performance Status 0-2
  • No prior anticancer therapy for pancreatic adenocarcinoma
  • No prior anticancer therapy of any kind within the last 5 years
  • Adequate hepatic, bone marrow, and renal function
  • Life expectance of > 12 weeks
  • Women of childbearing potential must have a negative serum pregnancy test

Exclusion criteria

  • Duodenal involvement of pancreatic cancer
  • Metastatic cancer
  • Active severe infection, or known chronic infection with HIV, hepatitis B virus, or hepatitis C virus
  • Cardiovascular disease including unstable angina, therapy for life-threatening ventricular arrhythmia, myocardial infarction, stroke, or congestive heart failure within the last 6 months
  • Life-threatening visceral disease or other severe concurrent disease
  • Pregnant or breastfeeding
  • Anticipated patient survival under 3 months
  • Another active malignancy within the past 5 years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.

Treatment and study plan

Cyberknife radiation and gemcitabine

Radiation

25 Gray of radiation will be given in 5 fractions using the Cyberknife Gemcitabine 1000 mg/m2 intravenously will be given once a week on days 1, 8, and 15 of every 28-day cycle for 6 cycles

Other names: Gemcitabine, Gemzar

Primary outcomes

  1. To demonstrate that radiation treatments can be reproduced as determined by evaluation of the prescription isodose curves

    Time frame: 10 days

Secondary outcomes

  1. Acute and late toxicity as determined by patient self-reporting instruments that assess gastrointestinal side effects

    Time frame: 6 months

  2. Quality of life as determined by patient self-reporting instruments

    Time frame: 6 months

  3. Acute stomach/duodenal mucosa injury as assessed by upper endoscopy

    Time frame: one month

  4. Late stomach/duodenal mucosa injury as assessed by upper endoscopy

    Time frame: 6 months

  5. Feasibility of integrating metabolomic analysis into the evaluation of patients with unresectable pancreatic cancer undergoing chemotherapy and radiation therapy measured by the ability to collect tumor specimens

    Time frame: 6 months

  6. The feasibility of measuring pancreatic cancer stem cell populations by analysis of fine needle aspirate specimens

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Registry information

Official study title

A Pilot Study of Full Dose Gemcitabine and Hypofractionated Stereotactic Radiosurgery in the Treatment of Unresectable Pancreatic Cancer

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jan 18, 2010
Registry last updated
Apr 24, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.