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A Dose Escalation Trial of Stereotactic Body Radiotherapy (SBRT) After Induction Chemotherapy for Locally Advanced Pancreatic Cancer


2015-12


2024-12-16


2024-12-16


11

Study Overview

A Dose Escalation Trial of Stereotactic Body Radiotherapy (SBRT) After Induction Chemotherapy for Locally Advanced Pancreatic Cancer

The purpose of this study is to find out the maximum dose of SBRT that can be safely given after chemotherapy for treatment of pancreatic cancer that cannot be removed surgically.

N/A

  • Pancreatic Cancer
  • RADIATION: Stereotactic Body Radiotherapy (SBRT)
  • 15-109

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2015-12-29  

N/A  

2024-12-17  

2015-12-29  

N/A  

2024-12-20  

2015-12-31  

N/A  

2024-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Stereotactic Body Radiotherapy (SBRT)

Cohorts 1-3 After completion of induction chemotherapy, stereotactic body radiotherapy (SBRT) will be administered in 3 fractions, every other day, on an outpatient basis. Dose escalation will start with dose level 1 (9 Gy x 3 fractions) and increase by 1

RADIATION: Stereotactic Body Radiotherapy (SBRT)

Primary Outcome MeasuresMeasure DescriptionTime Frame
maximum tolerated dose (MTD) of SBRTDose limiting toxicities (DLT) are defined by ≥ Grade 3 treatment-related GI toxicity within 3 months of SBRT. These include: (1) Bowel (includes bowel perforation, obstruction, or hemorrhage) and (2) Stomach (bleeding ulcer, perforation). We will employ a standard 3+3 dose-escalation scheme. Patients will be accrued to the study in cohorts of 3.after at least 3 months of induction chemortherapy
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

    Inclusion Criteria:

  • Histologically or cytopathologically confirmed adenocarcinoma of the pancreas.
  • Locally advanced, unresectable pancreatic cancer as confirmed by the multidisciplinary input from a hepatobiliary surgeon and as defined on CT as having tumor abutment of >180° (> 50%) of the circumference of the superior mesenteric artery (SMA) or celiac axis, unreconstructable superior mesenteric vein (SMV) or PV involvement.
  • No evidence of distant metastasis either prior to or after induction chemotherapy.
  • Completion of at least 3 months, but no more than 6 months of standard induction chemotherapy for LAPC, which may include FOLFIRINOX or gemcitabine and nab-paclitaxel, preferably within 2-4 weeks but no longer than 8 weeks.
  • Pancreatic tumor size ≤ 5 cm.
  • Age ≥18 years
  • ECOG 0-1.
  • Patients must have acceptable organ and marrow function as defined below:


  • Leukocytes >3,000/uL
  • Absolute neutrophil count >1,500/uL
  • Platelets >50,000/uL
  • Total bilirubin Within 2 x upper limit of normal
  • AST (SGOT)/ALT (SGPT) <2.5 x institutional upper limit of normal
  • Creatinine-Creatinine clearance Within 1.5 x upper limit of normal OR >60 mL/min for patients with creatinine levels above institutional normal
  • Ability to understand and follow the breathing instructions involved in the respiratory gating procedure or to tolerate compression sufficient to reduce fiducial motion to ≤ 5mm
  • Ability to understand and the willingness to sign a written informed consent document.

  • Exclusion Criteria:

  • Patients who have had prior abdominal radiotherapy.
  • Patients receiving any other investigational agents
  • 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.
  • Contraindication to Magnetic Resonance Imaging
  • Patients in which iodine contrast is contraindicated
  • 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 levels greater than 35 mIU/mL. A negative urine or serum pregnancy test must be obtained within 14 days prior to the start of study therapy in all women of child-bearing potential. Male subjects must also agree to use effective contraception for the same period as above.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Marsha Reyngold, MD, PhD, Memorial Sloan Kettering Cancer Center

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available