NCT01051284

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 pancreatic-cancer

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

April 24, 2012

Status Verified

April 1, 2012

Enrollment Period

1.3 years

First QC Date

January 15, 2010

Last Update Submit

April 23, 2012

Conditions

Pancreatic Cancer

Keywords

PancreasNewly diagnosedCyberknifeGemcitabine

Outcome Measures

Primary Outcomes (1)

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

    10 days

Secondary Outcomes (6)

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

    6 months

  • Quality of life as determined by patient self-reporting instruments

    6 months

  • Acute stomach/duodenal mucosa injury as assessed by upper endoscopy

    one month

  • Late stomach/duodenal mucosa injury as assessed by upper endoscopy

    6 months

  • 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

    6 months

  • +1 more secondary outcomes

Study Arms (1)

Cyberknofe and Gemcitabine

EXPERIMENTAL

Cyberknife radiation and 6 cycles Gemcitabine

Radiation: Cyberknife radiation and gemcitabine

Interventions

Cyberknife radiation and gemcitabineRADIATION

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

Also known as: Gemcitabine, Gemzar
Cyberknofe and Gemcitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Medical Center

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

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Michael J Pishvaian, MD, PhD

    Georgetown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 15, 2010

First Posted

January 18, 2010

Study Start

November 1, 2009

Primary Completion

February 1, 2011

Study Completion

March 1, 2012

Last Updated

April 24, 2012

Record last verified: 2012-04

Locations

US(1)