Clinical Trials /

Respiratory-gated Stereotactic Body Radiation Therapy for Adenocarcinoma of the Pancreas or Periampullary Region

NCT02780648

Description:

This is a single center, single arm unblinded prospective study of the safety of pancreatic stereotactic body radiation therapy (SBRT) in patients with unresectable, borderline resectable, or recurrent pancreatic/periampullary cancers who have previously undergone treatment with chemotherapy, surgery, photodynamic therapy, conventionally fractionated radiation treatment, or any combination of these therapies. Primary Objective • To estimate rates of acute (within 3 months of treatment) grade 3 or greater gastrointestinal and hematologic toxicity in patients treated with Linac-based SBRT for pancreatic or periampullary cancers who have previously received other treatment. Secondary Objectives - To estimate rates of late (> 3 months after treatment) grade 2 gastritis, enteritis, fistula, and ulcer, or any other grade 3 or greater gastrointestinal toxicity in patients treated with Linac-based SBRT for pancreatic or periampullary cancers - To estimate rates of local progression, overall survival, metastasis-free survival, and progression-free survival in patients with pancreatic or periampullary cancers treated with fractionated Linac-based SBRT. - To evaluate the ability of Linac-based SBRT to provide pain control in patients with pain related to a pancreatic or periampullary tumor. - To evaluate quality of life in patients undergoing treatment with Linac-based SBRT for pancreatic or periampullary cancers.

Related Conditions:
  • Ampulla of Vater Pancreatobiliary Type Adenocarcinoma
  • Pancreatic Adenocarcinoma
  • Periampullary Adenocarcinoma
Recruiting Status:

Active, not recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Respiratory-gated Stereotactic Body Radiation Therapy for Adenocarcinoma of the Pancreas or Periampullary Region
  • Official Title: Pilot Study of Respiratory-gated Stereotactic Body Radiation Therapy for Borderline Resectable, Unresectable, or Recurrent/Residual Adenocarcinoma of the Pancreas or Periampullary Region

Clinical Trial IDs

  • ORG STUDY ID: IUSCC-0565
  • SECONDARY ID: 1601638414
  • NCT ID: NCT02780648

Conditions

  • Pancreatic Neoplasms

Purpose

This is a single center, single arm unblinded prospective study of the safety of pancreatic stereotactic body radiation therapy (SBRT) in patients with unresectable, borderline resectable, or recurrent pancreatic/periampullary cancers who have previously undergone treatment with chemotherapy, surgery, photodynamic therapy, conventionally fractionated radiation treatment, or any combination of these therapies. Primary Objective • To estimate rates of acute (within 3 months of treatment) grade 3 or greater gastrointestinal and hematologic toxicity in patients treated with Linac-based SBRT for pancreatic or periampullary cancers who have previously received other treatment. Secondary Objectives - To estimate rates of late (> 3 months after treatment) grade 2 gastritis, enteritis, fistula, and ulcer, or any other grade 3 or greater gastrointestinal toxicity in patients treated with Linac-based SBRT for pancreatic or periampullary cancers - To estimate rates of local progression, overall survival, metastasis-free survival, and progression-free survival in patients with pancreatic or periampullary cancers treated with fractionated Linac-based SBRT. - To evaluate the ability of Linac-based SBRT to provide pain control in patients with pain related to a pancreatic or periampullary tumor. - To evaluate quality of life in patients undergoing treatment with Linac-based SBRT for pancreatic or periampullary cancers.

Detailed Description

      Patients will receive 5 fractions of 5 gray (Gy) or 6.6 Gy delivered over a five-day period
      based on whether or not they have received prior radiation therapy to the pancreatic region.
      Treatment may be delivered over 2 weeks, provided that the patient receives at least 2
      fractions per week. Initial patient positioning will be based on volumetric kV (cone-beam
      computerized tomography) imaging with shifts to bony anatomy as appropriate. Orthogonal kV/MV
      or kV/kV projection imaging will be used to verify the location of the fiducials prior to
      delivery of the first treatment beam. A secondary shift based on the location of fiducials
      may be utilized, as indicated by the position of the fiducials. For free-breathing
      treatments, kV fluoroscopic images should be obtained to confirm the anticipated position of
      these fiducials during the entire respiratory cycle. Active monitoring of treatment delivery
      accuracy will be accomplished using kV and/or MV projection imaging, either immediately
      before or during all (or a subset of) treatment fields. Patient-specific dosimetric quality
      assurance (QA) will be performed as per standard practice in the Department of Radiation
      Oncology, Indiana University School of Medicine.
    

Trial Arms

NameTypeDescriptionInterventions
Stereotactic Body RadiationExperimentalPatients will receive 5 fractions of 5 Gy or 6.6 Gy (dose depending upon whether or not they have received prior radiation therapy to the pancreatic region) delivered over a five-day period.

    Eligibility Criteria

            Inclusion Criteria
    
              -  Age >18 years.
    
              -  Karnofsky Performance Status >70%
    
              -  Histologically confirmed adenocarcinoma of the pancreas or ampulla of Vater; at least
                 the majority of the histopathologic specimen must be identified as adenocarcinoma as
                 opposed to another histologic subtype. In patients with a diagnosis of recurrent
                 disease (based on radiographic progression and/or rising CA19-9 levels) and a history
                 of a biopsy-proven adenocarcinoma of the pancreas or the ampulla of Vater, repeat
                 biopsy of the recurrence site is not required for participation of the trial.
    
              -  Pancreatic or periampullary tumors must be less than 8.0 cm in greatest axial
                 dimension at the time of treatment planning.
    
              -  Patients who have been treated with any combination of surgical resection and
                 neoadjuvant/adjuvant conventional chemoradiation therapy for resectable disease or
                 conventional chemoradiation as definitive treatment for unresectable or borderline
                 resectable disease are eligible for the study, provided that at least 180 days have
                 elapsed since completing any previous radiation treatment. Patients who have been
                 receiving continued chemotherapy following their initial radiation treatment are
                 eligible regardless of when the most recent chemotherapy was received. Those patients
                 who have received prior radiation therapy will constitute Cohort A and will receive
                 stereotactic body radiation (SBRT) as 5 gray (Gy) x 5.
    
              -  Patients who have not previously undergone radiation therapy can have a history of
                 treatment with either chemotherapy (for unresectable/borderline resectable disease) or
                 any combination of surgery and chemotherapy (for resectable disease). Patients with no
                 history of prior radiation treatment will constitute Cohort B and will receive SBRT as
                 6.6 Gy x 5. Please note that patients must have received at least two cycles of
                 chemotherapy (with selection of drugs at the discretion of the treating oncologist)
                 before SBRT treatment on protocol.
    
              -  Acceptable organ and marrow function as defined below (within 2 weeks prior to
                 radiotherapy):
    
                   -  Leukocytes >3,000/μL
    
                   -  Absolute neutrophil count >1,500μL
    
                   -  Platelets >100,000/μL
    
                   -  Total Bilirubin ≤1.5x institutional upper limit of normal
    
                   -  Aspartate transaminase (AST(SGOT))/Alanine transaminase (ALT(SGPT)) <2.5x
                      institutional upper limit of normal
    
                   -  Creatinine ≤ institutional upper limit of normal OR creatinine clearance >60
                      mL/min/1.73 m2 for patients with creatinine levels above institutional normal
    
              -  Ability to understand and the willingness to sign a written informed consent document.
    
              -  Life expectancy > 3 months.
    
              -  Radio-opaque markers must be present within the tumor bed. In patients who have
                 undergone surgical resection, radio-opaque surgical clips within the tumor bed can be
                 used as fiducials. Patients without surgical clips in the tumor bed must be able to
                 have fiducials placed endoscopically, laparoscopically, or through a CT- or
                 ultrasound-guided technique. If not, the tumor must be posterior and adjacent to the
                 aorta, and treatment will only be permitted at the discretion of the Principal
                 Investigator.
    
            Exclusion Criteria
    
              -  Age < 18 years.
    
              -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
                 infection (or infections requiring systemic antibiotic treatment), active upper GI
                 ulceration or hemorrhage, symptomatic congestive heart failure, unstable angina
                 pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
                 limit compliance with study requirements.
    
              -  Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder
                 cancer, early stage prostate cancer, or carcinoma in situ of the cervix. Patients with
                 a previous non-pancreatic, non-periampullary malignancy without evidence of disease
                 for > 5 years will be allowed to enter the trial.
    
              -  Pregnant and breastfeeding women are excluded as are women of child-bearing potential
                 who are unwilling or unable to use an acceptable method of birth control (hormonal or
                 barrier method of birth control; abstinence) to avoid pregnancy for the duration of
                 the study. Should a woman become pregnant or suspect she is pregnant while
                 participating in this study, she should inform her treating physician immediately.
    
              -  Women who are not post-menopausal (as defined in Appendix III) and have a positive
                 urine or serum pregnancy test or refuse to take a pregnancy test.
    
              -  Patients with a life expectancy of < 3 months.
    
              -  Patients with metastatic disease.
    
              -  Patients with evidence of gross tumor invasion into the lumen of the stomach or small
                 bowel are not eligible; if imaging suggests luminal invasion of tumor, this must be
                 ruled out endoscopically before the patient can be enrolled on study.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Acute toxicity rates of grade 3 gastrointestinal and hematologic toxicities (as raw percentage)
    Time Frame:3 months after treatment
    Safety Issue:
    Description:Toxicities per Common Terminology Criteria for Adverse Events (CTCAE) 4.0

    Secondary Outcome Measures

    Measure:Late toxicity rates of grade 3 gastrointestinal and hematologic toxicities (as raw percentage)
    Time Frame:6 months, 9 months, and 1 year after treatment
    Safety Issue:
    Description:Toxicities per CTCAE 4.0
    Measure:Overall survival rates
    Time Frame:1 year after treatment
    Safety Issue:
    Description:
    Measure:Progression-free survival rates
    Time Frame:1 year after treatment
    Safety Issue:
    Description:
    Measure:Metastasis-free survival rates
    Time Frame:1 year after treatment
    Safety Issue:
    Description:
    Measure:Patient self-report of pain control
    Time Frame:1 month and 3 months after treatment
    Safety Issue:
    Description:Measured by Wong-Baker FACES 0-10 scale
    Measure:Patient self-report of quality of life
    Time Frame:1 month, 3 months, 6 months, 9 months, and 1 year after treatment
    Safety Issue:
    Description:Measured by EORTC Quality of Life (QOL)-Q scale

    Details

    Phase:Early Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Susannah Ellsworth

    Trial Keywords

    • stereotactic radiotherapy
    • pancreatic adenocarcinoma

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