Phase II Gemcitabine + Fractionated Stereotactic Radiotherapy for Unresectable Pancreatic Adenocarcinoma
Condition: Pancreatic Cancer
MeSH terms: Adenocarcinoma
Intervention: CyberKnife based stereotactic radiotherapy; Gemcitabine; Fludeoxyglucose (18F) (FDG)
Intervention description: Initial orthogonal images will be obtained to confirm location of fiducial seeds.
Synchrony respiratory tracking system must be used to correct for respiratory associated tumor motion. This system utilizes a series of optical diodes placed upon the patient's chest wall. While the orthogonal images are obtained, the computer generates a model correlating the position of the chest wall with the position of the internal fiducials. This model is continuously updated during treatment to correct for subtle changes in tumor location.
Quality assurance will be performed as per standard practice at each participating institution.; Treatment calculated per the needs of each patient and given at the instruction of the investigator; iv (intravenous).; FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv
Intervention MeSH terms: Gemcitabine; Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multi-institutional trial aims to evaluate the potential benefit and side effects of
      adding fractionated stereotactic body radiotherapy/surgery (SBRT) before and after
      chemotherapy with gemcitabine for locally advanced pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

        3.1.1 Histologically confirmed adenocarcinoma of the pancreas.

        3.1.2 Unresectable disease as determined by a pancreatic cancer surgeon and assessment at a
        GI oncology tumor board (JHU - Johns Hopkins University, SU - Stanford University, or MSKCC
        - Memorial Sloan Kettering Cancer Center).

        3.1.3 Up to 3 weeks of gemcitabine chemotherapy is allowed prior to SBRT.

        3.1.4 Pancreatic tumors must be less than 7.5 cm in greatest axial dimension (or <1000 cc
        in volume) at the time of treatment planning.

        3.1.5 No prior upper abdominal or liver radiation therapy.

        3.1.6 No chemotherapy within 2 weeks of radiotherapy, or chemotherapy within parameters set
        by Investigator for each institution.

        3.1.7 Age >=18 years.

        3.1.8 No infections requiring systemic antibiotic treatment.

        3.1.9 Karnofsky >= 70% (see Appendix III).

        3.1.10 Patients must have acceptable organ and marrow function as defined below (within 1
        month prior to radiotherapy):

          -  leukocytes: >=3,000/microliter (uL)

          -  absolute neutrophil count: >=1,500uL

          -  platelets: >=100,000/uL

          -  total bilirubin: within 1.5 times (1.5X) normal institutional limits

          -  AST (aspartate aminotransferase)(SGOT -Serum glutamic oxaloacetic
             transaminase)/ALT(alanine aminotransferase)(SGPT-serum glutamic-pyruvic transaminase):
             <=2.5 X institutional upper limit of normal

          -  creatinine: within normal institutional limits

        OR

        - creatinine clearance: >=60 mL/min/1.73 m^2 for patients with creatinine levels above
        institutional normal

        3.1.11 The effects of radiation on the developing human fetus at recommended therapeutic
        doses can result in death of the fetus. If a woman is of child-bearing potential, a
        negative urine or serum pregnancy test must be demonstrated prior to treatment. Women of
        childbearing potential and men must agree to use adequate contraception (hormonal or
        barrier method of birth control; abstinence) for the duration of study participation and
        for up to 4 weeks following the study. Should a woman become pregnant or suspect she is
        pregnant while participating in this study, she should inform her treating physician
        immediately.

        3.1.12 Ability to understand and the willingness to sign a written informed consent
        document.

        3.1.13 Life expectancy > 6 months

        Exclusion Criteria:

        3.2.1 Patients who have had prior radiotherapy to the upper abdomen.

        3.2.2 Patients receiving more than 1 cycle of gemcitabine chemotherapy or other therapy
        prior to SBRT.

        3.2.3 Children are excluded because pancreatic tumors rarely occur in this age group.
        Furthermore, treatment requires a great deal of patient cooperation including the ability
        to lie still for several hours in an isolated room.

        3.2.4 No laboratory personnel will be included.

        3.2.5 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.

        3.2.6 Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder
        cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy without
        evidence of disease for > 5 years will be allowed to enter the trial.

        3.2.7 Pregnant and breastfeeding women are excluded. Women of child-bearing potential who
        are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for
        the entire study period and for up to 4 weeks after the study are excluded. This applies to
        any woman who has experienced menarche and who has not undergone successful surgical
        sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive
        months, or women on hormone replacement therapy with serum FSH (follicle stimulating
        hormone) levels greater than 35 IU/mL (international units/milliliter). A negative urine or
        serum pregnancy test must be obtained within 72 hours prior to the start of study
        medication in all women of childbearing potential. Male subjects must also agree to use
        effective contraception for the same period as above.