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Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01360593
Recruitment Status : Active, not recruiting
First Posted : May 25, 2011
Last Update Posted : January 21, 2020
Information provided by (Responsible Party):
Dwight Heron, University of Pittsburgh

Brief Summary:
The current study seeks to further investigate the impact of up-front systemic therapy in combination with fractionated SBRT for potentially resectable, locally-advanced pancreatic adenocarcinoma.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gemcitabine Drug: Capecitabine Radiation: Stereotactic Body Radiation Therapy (SBRT) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma A Prospective Evaluation in Patients With Locally Advanced Pancreas Cancer
Study Start Date : July 2011
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Gem, Xeloda, SBRT Drug: Gemcitabine

Gemcitabine will be administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:

Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.

Other Name: Gemzar

Drug: Capecitabine

Capecitabine will be taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:

Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.

Other Name: Xeloda

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Fractionated SBRT will be delivered to patients that have stable disease, partial response, or complete response after chemo in the following manner:

12 Gy x 3 fractions (36 Gy total) This will be given every other day.

Other Names:
  • CyberKnife
  • Trilogy
  • True Beam
  • Radiosurgery
  • SBRT

Primary Outcome Measures :
  1. Local progression-free survival (LPFS) achieved in subjects with locally-advanced, potentially resectable pancreatic adenocarcinoma treated with SBRT and gemcitabine/capecitabine chemotherapy [ Time Frame: 24 months ]
    In this study, LPFS is defined as the time from enrollment to first documentation of progressive disease (PD) in the target lesion. Death or development of distant disease is not regarded as an event. For patients that undergo surgical resection, local progression will be defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.

Secondary Outcome Measures :
  1. Objective response rate, time to progression (TTP) and overall survival (OS) [ Time Frame: 24 months ]
    TTP is defined as the time from enrollment to disease progression. Disease progression will be defined as PD in the target volume, or development of distant disease. OS is defined as the length of time from enrollment to confirmed death from any cause.

  2. Number of patients that are able to undergo a margin-negative resection after neoadjuvant therapy [ Time Frame: 24 months ]
    All patients that undergo attempted surgical evaluation will have their pathology records reviewed and discussed with the operating surgeon to determine margin status. Margins will be classified as negative, close (1-2.5mm), microscopically positive, and grossly positive.

  3. QOL of subjects treated with SBRT for unresectable locally-advanced pancreatic adenocarcinoma [ Time Frame: 24 months ]
    QOL evaluation will be administered prior to SBRT, after completion of SBRT, and at each follow-up. The survey will be the FACT-G

  4. Measure acute and late toxicities associated with SBRT for locally advanced pancreas cancer [ Time Frame: 24 months ]
    All patients will be monitored for potential treatment-related toxicity throughout treatment as detailed in the schema. Toxicity will be graded according to the CTCAE v4. Acute toxicity is defined as toxicity occurring within 3 months of completion of SBRT. Late toxicity is defined as toxicity occurring greater than 3 months after treatment.

  5. Role of FDG-PET/CT in the setting of pancreatic cancer [ Time Frame: 24 months ]
    Ideally, all follow-up FDG-PET/CT scans after chemo will be performed on the same scanner to help limit variability in the SUVs detected by different scanners. For those patients with non-FDG avid tumors, their response to therapy will be assessed by CT scan. The most recent consensus recommendations by the NCI on assessing PET response indicate semi-quantitative SUV (standard uptake value) analysis based on lean body mass and/or body surface area be used in determining 18F-FDG uptake. We will use the EORTC 1999 criteria for defining 18F-FDG response

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically proven adenocarcinoma of the pancreas
  • Subjects will be staged according to the 2010 AJCC staging system with pathologic stage T1-4, N0-1 being eligible; and have a primary tumor of the pancreas (i.e., pancreatic head, neck, uncinate process, body/tail
  • Tumor must be deemed to be borderline resectable or locally advanced by radiographic criteria defined by Varadhachary et al.26 Final CT confirmation of surgical staging/eligibility will be by two expert pancreatic surgeons
  • Disease confined to locoregional site confirmed by FDG-PET/CT or CT and diagnostic staging laparoscopy to ensure no occult peritoneal implants
  • Disease must be encompassed in a reasonable SBRT "portal" as defined by the treating radiation oncologist
  • Measurable disease on imaging studies (MRI, CT, FDG-PET/CT or physical exam), including maximum diameter/dimension, must be present for assessment of response
  • Karnofsky performance status > 70 (ECOG 0-1)
  • Age > 18
  • Estimated life expectancy > 12 weeks
  • Patient must have adequate renal function as defined by serum creatinine<1.5mg/dl obtained within 28 days prior to registration
  • Patient must have adequate bone marrow function as defined by absolute neutrophil count>1500/mcl and platelets>100,000/mcl, obtained within 28 days prior to registration
  • Patient must have adequate hepatic function as defined by total bilirubin <1.5 x IULN(institutional upper limit of normal) and either SGOT or SGPT <2.5x IULN, obtained within 28 days prior to registration.
  • Patient must be able to swallow enteral medications. Patient must not require a feeding tube. Patient must not have intractable nausea or vomiting, GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, or uncontrolled inflammatory bowel disease (Chron's, ulcerative colitis).
  • Diabetes must be controlled prior to FDG-PET/CT scanning (blood glucose <200 mg/dL)
  • Ability to provide written informed consent
  • Patient must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, history of myocardial infarction or cerebrovascular accident within 3 months prior to registration, uncontrolled diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patient must not be pregnant because of the risk of harm to the fetus. Nursing women may participate only if nursing is discontinued, due to the possibility of harm to nursing infants from the treatment regimen. Women/men of reproductive potential must agree to use an effective contraception method.

Exclusion Criteria:

  • Non-adenocarcinomas, adenosquamous carcinomas, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas are not eligible.
  • Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies
  • Subjects with recurrent disease
  • Prior radiation therapy to the upper abdomen or liver
  • Prior chemotherapy
  • Subjects in their reproductive age group should use an effective method of birth control. Subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study
  • Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator
  • Concurrent serious infection
  • Previous or current malignancies of other histologies within the last 5 years, with the exception of cervical carcinoma in situ, adequately treated basal cell or squamous cell carcinoma of the skin, and treated low-risk prostate cancer.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01360593

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United States, Pennsylvania
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Dwight Heron
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Principal Investigator: Dwight E Heron, MD UPMC Shadyside
Principal Investigator: Rodney Wegner, MD UPMC Shadyside
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Responsible Party: Dwight Heron, Vice Chairman of Clinical Affairs, University of Pittsburgh Identifier: NCT01360593    
Other Study ID Numbers: 08-139
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Keywords provided by Dwight Heron, University of Pittsburgh:
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs