A Study Of Pre-Operative Cyberknife In Patients With Potentially Resectable Pancreas Cancer

Study Overview

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

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

This study is evaluating the role of neoadjuvant chemotherapy and CyberKnife therapy in increasing the number of patients who are able to successfully undergo definitive surgical management of their pancreatic carcinoma. In addition, we will evaluate the associated therapeutic toxicities and gather data regarding the quality of life indicators at similar time intervals for an improved overall assessment of the effects of this course of treatment on our patients. Surgery is deemed the only curative technique for pancreatic cancer. Unfortunately, more than 80% of patients who present with the disease cannot be cured by resection. The literature reports median survival for resectable patients on the order of 19 months, with a 20% 5 year survival rate. For patients unable to undergo surgical resection, the median survival in the literature is approximately 11 months. In the absence of the proposed protocol, this patient population would be treated as per the standard of care for locally advanced non-metastatic surgically unresectable pancreatic malignancies, which would include a combination of chemotherapy and radiation therapy. The anticipated Grade 4 and above toxicity would be approximately 3-5% from this regimen. The rate of G 4 and above toxicity is not known with the use of this neoadjuvant regimen, and, therefore, this constitutes the major risk associated with this protocol therapy. The associated benefit, however, is the anticipated improvement in median survival that these patients may derive from the ability to successfully undergo surgical resection. A secondary proposed benefit is the potential for reduction in the treatment associated toxicity with this altered multimodality schedule when compared to traditional multimodality care or non-surgical care of locally advanced pancreatic malignancy.

Pancreas Cancer
Pancreatic Cancer
Adenocarcinoma of the Pancreas
Pancreas Adenocarcinoma
Pancreatic Adenocarcinoma

DRUG: Gemcitabine
RADIATION: Stereotactic Radiosurgery

12-169

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-10-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-03-08
First Submitted that Met QC Criteria 2016-03-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-03-14
First Posted (ESTIMATED) 2016-03-14	Results First Posted N/A	Last Verified 2015-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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 cy	DRUG: Gemcitabine RADIATION: Stereotactic Radiosurgery

Participant Group/Arm

Intervention/Treatment

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 cy

DRUG: Gemcitabine

RADIATION: Stereotactic Radiosurgery

Primary Outcome Measures	Measure Description	Time Frame
percentage of subjects who successfully undergo pancreaticoduodenectomy	Evaluate the percentage of subjects who successfully undergo pancreaticoduodenectomy	2 months

Secondary Outcome Measures	Measure Description	Time Frame
Overall Survival		6 months, 1 year, 5 years
Tumor response per RECIST 1.1		2-8 months
Quality of Life		2-8 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		12 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Kimberly Krieger

Phone Number: 856-735-6237

Email: krieger-kimberly@cooperhealth.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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