A Study of Pre-Operative Cyberknife in Patients With Potentially Resectable Pancreas Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is evaluating stereotactic radiosurgery (CyberKnife) plus chemotherapy for the treatment of potentially resectable adenocarcinoma of the pancreas

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cooper Health System
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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