Pancreatic CancerPhase 1NCT01051284
A Study of Gemcitabine and Cyberknife Radiation Therapy for Pancreatic Cancer
A Phase 1 study testing Cyberknife radiation and gemcitabine in people with Pancreatic Cancer, run by Georgetown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Cyberknife radiation and gemcitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Mar 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Pilot Study of Full Dose Gemcitabine and Hypofractionated Stereotactic Radiosurgery in the Treatment of Unresectable 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.
Read the detailed description
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Cyberknife radiation and gemcitabine
- Keywords
- Pancreas, Newly diagnosed, Cyberknife, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyberknife radiation and gemcitabineRadiation
Also called Gemcitabine, Gemzar
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
| Study group | Role | What they receive |
|---|---|---|
| Cyberknofe and Gemcitabine | Experimental | Cyberknife radiation and 6 cycles Gemcitabine Receives: Radiation: Cyberknife radiation and gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that radiation treatments can be reproduced as determined by evaluation of the prescription isodose curves
Measured: 10 days
Secondary outcomes (6)
Acute and late toxicity as determined by patient self-reporting instruments that assess gastrointestinal side effects
Measured: 6 months
Quality of life as determined by patient self-reporting instruments
Measured: 6 months
Acute stomach/duodenal mucosa injury as assessed by upper endoscopy
Measured: one month
Late stomach/duodenal mucosa injury as assessed by upper endoscopy
Measured: 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
Measured: 6 months
The feasibility of measuring pancreatic cancer stem cell populations by analysis of fine needle aspirate specimens
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionFeb 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J Pishvaian, Georgetown University
- Investigators
- Michael J Pishvaian, MD, PhD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051284
- Sponsor's protocol ID
- 2009-169
- Status last verified
- Apr 2012
- First submitted
- 15 Jan 2010
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Full Dose Gemcitabine and Hypofractionated Stereotactic Radiosurgery in the Treatment of Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01051284
- Acronym / sponsor ID
- 2009-169
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreas, Newly diagnosed, Cyberknife, Gemcitabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 18 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyberknofe and Gemcitabine | Experimental | Radiation: Cyberknife radiation and gemcitabineCyberknife radiation and 6 cycles Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyberknife radiation and gemcitabineAlso: Gemcitabine, Gemzar25 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 | Radiation | Cyberknofe and Gemcitabine |
Primary outcome
To demonstrate that radiation treatments can be reproduced as determined by evaluation of the prescription isodose curves
Time frame: 10 days
6 secondary outcomes
Acute and late toxicity as determined by patient self-reporting instruments that assess gastrointestinal side effects
Time frame: 6 months
Quality of life as determined by patient self-reporting instruments
Time frame: 6 months
Acute stomach/duodenal mucosa injury as assessed by upper endoscopy
Time frame: one month
Late stomach/duodenal mucosa injury as assessed by upper endoscopy
Time frame: 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
Time frame: 6 months
The feasibility of measuring pancreatic cancer stem cell populations by analysis of fine needle aspirate specimens
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Pishvaian, MD, PhD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyberknife radiation and gemcitabine in people with Pancreatic Cancer, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate that radiation treatments can be reproduced as determined by evaluation of the prescription isodose curves (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2012.