A Study of Pre-Operative Cyberknife in Patients With Potentially Resectable Pancreas Cancer
Status unconfirmed · Early Phase 1
Conditions studied: Pancreas Cancer, Pancreatic Cancer, Adenocarcinoma of the Pancreas, Pancreas Adenocarcinoma, Pancreatic Adenocarcinoma
In brief
This study is evaluating stereotactic radiosurgery (CyberKnife) plus chemotherapy for the treatment of potentially resectable adenocarcinoma of the pancreas
Key facts
- Study ID
- NCT02707315
- Run by
- The Cooper Health System
- People needed
- 15
- Starts
- 2013-01-01
- Last updated by the study team
- 2016-03-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Pathologically confirmed adenocarcinoma of the pancreas
- Resectable or potentially resectable disease based on the following imaging criteria performed < 4 weeks from study entry and as determined by local review (Cooper radiologist)
- No extrapancreatic extension to nearby organs (ie; small bowel)
- No SMV/PV >180 degree involvement and/or reconstructable (as determined by Surgeon) occlusion
- No SMA Abutment TVI<180 degrees
- No Celiac trunk abutment Total volume involved < 180 degrees
- Note that both resectable and potentially resectable patients are eligible
- ECOG ≤ 2
- Adequate hematologic and end organ function as defined by
- Hepatic transaminase levels < 3 x normal
- Total bilirubin < 5 mg/dl (if stented)
- Serum creatinine level < 1.6 mg/dl
- Absolute neutrophil count > 1,500cells/mm3
- Platelet count > 100,000 cells/mm3
- Medical status suitable for consideration of major pancreatic surgery
- Age >18 years
- Women of childbearing age and male participants must practice adequate contraception (hormonal or barrier method of birth control; abstinence) prior to and throughout study treatment.
- Life expectancy > 3 months
- Ability to understand and the willingness to sign a written informed consent.
You may not qualify if…
- Prior invasive malignancy within 5 years other than pancreatic adenocarcinoma
- Prior radiotherapy to the upper abdomen
- Severe comorbidity rendering a candidate ineligible for surgical resection
- Local, regional or distant extrapancreatic disease
- Patients of childbearing age who are unwilling or unable to practice contraception
- Failure to meet any of the above eligibility criteria
- Inability to undergo MRI with contrast for treatment planning
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients may not be receiving any other investigational nor commercial agents with therapeutic intent to treat pancreatic cancer while on this trial.
- unresectable pancreatic cancer based on the following imaging criteria performed < 4 weeks from study entry and as determined by local review (Cooper radiologist)
- Extrapancreatic extension to nearby organs (ie; small bowel)
- SMV/PV >180 degree involvement and/or reconstructable (as determined by Surgeon) occlusion
- SMA Abutment TVI<180 degrees
- Celiac trunk abutment Total volume involved < 180 degrees
- Distant metastases
Where it is running
- MD Anderson Cancer Center at Cooper — Camden, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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