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

NCT02707315 | Unknown Early Phase 1 DMC

• 1 other identifier: 12-169
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Cyber Knife; CyberKnife; Stereotactic Radiosurgery; CK

Outcome Measures

Primary Outcomes (1)

• percentage of subjects who successfully undergo pancreaticoduodenectomy

  Evaluate the percentage of subjects who successfully undergo pancreaticoduodenectomy

  2 months

Secondary Outcomes (4)

• 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

Study Arms (1)

A

EXPERIMENTAL

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; Radiation: Stereotactic Radiosurgery

Interventions

Gemcitabine DRUG

Also known as: Gemzar

A

Stereotactic Radiosurgery RADIATION

Also known as: CyberKnife, Cyber Knife, CK

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

MD Anderson Cancer Center at Cooper

Camden, New Jersey, 08103, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Kimberly Krieger

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: March 14, 2016
• Study Start: January 1, 2013
• Primary Completion: December 1, 2016
• Last Updated: March 14, 2016

Record last verified: 2015-10

Locations

US (1)