Recruiting

Early Phase 1

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

Sponsor:

The Cooper Health System

Code:

NCT02707315

Conditions

Pancreas Cancer

Pancreatic Cancer

Adenocarcinoma of the Pancreas

Pancreas Adenocarcinoma

Pancreatic Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gemcitabine

Stereotactic Radiosurgery

Study Details

Brief summary:

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

Conditions

Pancreas Cancer

Pancreatic Cancer

Adenocarcinoma of the Pancreas

Pancreas Adenocarcinoma

Pancreatic Adenocarcinoma

Study ID

NCT02707315

Start date

Jan, 2013

Status verified date

Oct, 2015

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: A

Chemotherapy:

Gemcitabine 1000 mg/m2 weekly x 3 on 28 day cycle

Radiation:

25 Gy over 5 fractions

Surgery:

surgical resection of pancreas

treatment plan:

1 cycle of chemotherapy, followed by stereotactic radiosurgery, followed by an additional 6 cycles of chemotherapy or surgical resection

Interventions

Gemcitabine

Stereotactic Radiosurgery

Primary outcome measure

percentage of subjects who successfully undergo pancreaticoduodenectomy [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Kimberly Krieger

856-735-6237 krieger-kimberly@cooperhealth.edu

Locations

MD Anderson Cancer Center at Cooper

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Kim Krieger

856-735-6237

More Information

Sponsor

The Cooper Health System

Last update posted

Mar 14, 2016

Last verified

Oct, 2015

Keywords

Cyber Knife
CyberKnife
Stereotactic Radiosurgery
CK

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cooper Health System on 2016-03-14.