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

March 8, 2016 updated by: The Cooper Health System
This study is evaluating stereotactic radiosurgery (CyberKnife) plus chemotherapy for the treatment of potentially resectable adenocarcinoma of the pancreas

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Early Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • MD Anderson Cancer Center at Cooper
        • Contact:
          • Kim Krieger
          • Phone Number: 856-735-6237

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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 cycles of chemotherapy or surgical resection
Drug: Gemcitabine
Other Names:
  • Gemzar
Radiation: Stereotactic Radiosurgery
Other Names:
  • CK
  • CyberKnife
  • Cyber Knife

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

The Cooper Health System

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 Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 2, 2015

First Submitted That Met QC Criteria

March 8, 2016

First Posted (Estimate)

March 14, 2016

Study Record Updates

Last Update Posted (Estimate)

March 14, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-169

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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