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

Primary Purpose

Pancreas Cancer, Pancreatic Cancer, Adenocarcinoma of the Pancreas

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
Stereotactic Radiosurgery
Sponsored by
The Cooper Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Cancer focused on measuring Cyber Knife, CyberKnife, Stereotactic Radiosurgery, CK

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MD Anderson Cancer Center at CooperRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

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

Outcomes

Primary Outcome Measures

percentage of subjects who successfully undergo pancreaticoduodenectomy
Evaluate the percentage of subjects who successfully undergo pancreaticoduodenectomy

Secondary Outcome Measures

Overall Survival
Tumor response per RECIST 1.1
Quality of Life
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Full Information

First Posted
October 2, 2015
Last Updated
March 8, 2016
Sponsor
The Cooper Health System
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1. Study Identification

Unique Protocol Identification Number
NCT02707315
Brief Title
A Study of Pre-Operative Cyberknife in Patients With Potentially Resectable Pancreas Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cooper Health System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer, Pancreatic Cancer, Adenocarcinoma of the Pancreas, Pancreas Adenocarcinoma, Pancreatic Adenocarcinoma
Keywords
Cyber Knife, CyberKnife, Stereotactic Radiosurgery, CK

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Radiosurgery
Other Intervention Name(s)
CyberKnife, Cyber Knife, CK
Primary Outcome Measure Information:
Title
percentage of subjects who successfully undergo pancreaticoduodenectomy
Description
Evaluate the percentage of subjects who successfully undergo pancreaticoduodenectomy
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
6 months, 1 year, 5 years
Title
Tumor response per RECIST 1.1
Time Frame
2-8 months
Title
Quality of Life
Time Frame
2-8 months
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly Krieger
Phone
856-735-6237
Email
krieger-kimberly@cooperhealth.edu
Facility Information:
Facility Name
MD Anderson Cancer Center at Cooper
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Krieger
Phone
856-735-6237

12. IPD Sharing Statement

Learn more about this trial

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

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