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Pulsed Low-Dose-Rate Radiation for the Treatment of Pancreatic Cancer

Trial Status: Active

This phase I trial investigates the side effects and best dose of pulsed low-dose-rate radiation (PLDR) in treating patients with pancreatic cancer. During PLDR, radiation delivered is broken into pulses over a relatively longer period of time. Undergoing PLDR may create a more favorable environment for tumor shrinkage with fewer side effects and less damage to surrounding vital organs compared to conventional radiation therapy. It also may make surgery a more likely option in patients who are not otherwise good candidates for surgery to remove the tumor.

Inclusion Criteria

  • Patients must have histologically or cytologically-confirmed pancreatic adenocarcinoma
  • Patients must have non-metastatic pancreatic cancer not appropriate for immediate surgical resection. This includes the following: * Any involvement (defined as loss of fat plane on contrast computed tomography [CT]) of any of the following vessels: ** Common hepatic artery ** Superior mesenteric artery ** Celiac axis ** Superior mesenteric vein ** Portal vein ** Aorta * These criteria will be judged by the operating surgeon in conjunction with a radiologist prior to enrollment * Poor performance status not immediately conducive to radical surgery * Other clinical reasoning by the treating physicians that supports pre-operative chemoradiation
  • Patients must have evaluable disease as determined by the physician
  • Planned surgical resection at the time of enrollment (may be initially staged as resectable, borderline resectable, or locally-advanced/unresectable)
  • Eastern Cooperative Oncology Group, or ECOG, performance status 0-2
  • Absolute neutrophil count (ANC) >= 1,500/ul
  • Platelets (PLT) >= 100,000/ul
  • Bilirubin less than 1.5 upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN
  • Serum creatinine < 1.5 x ULN
  • Prior chemotherapy allowed, but not mandatory. Patients who have undergone chemotherapy prior to participating in this study must have had a 2 week washout period at the time of signing the consent form
  • Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to registration. Postmenopausal woman must have been amenorrheic and nonlactating for at least 12 months to be considered of non-childbearing potential. Men and women of child bearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy is completed
  • Participants must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up

Exclusion Criteria

  • Radiological or cytologically confirmed metastatic disease
  • Patients who have had any prior therapy for pancreatic cancer, except chemotherapy
  • Concurrent non-study chemotherapy or biologic therapy
  • A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
  • Scleroderma or active connective tissue disease
  • Active inflammatory bowel disease
  • Serious, active infections requiring treatment with IV antibiotics
  • Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: ACTIVE
Contact: Joshua E. Meyer
Phone: 215-728-2667

PRIMARY OBJECTIVE:

I. To determine the safety of dose-escalated radiation, with PLDR technique, in the treatment of pancreatic cancer.

SECONDARY OBJECTIVES:

I. To assess the feasibility of surgery after PLDR radiation.

II. To develop a preliminary estimate of the efficacy of the investigational treatment.

III. To determine whether it is possible to assess the impact of PLDR radiation on pancreatic stroma and extracellular vesicles (EVs) in human patient samples in order to confirm preclinical findings.

OUTLINE: This is a dose-escalation study of PLDR.

Patients receive standard of care gemcitabine intravenously (IV) over 30 minutes on days 1, 8, and 15 prior to undergoing PLDR. Patients then undergo PLDR radiation consisting of either intensity-modulated radiation therapy (IMRT) or volume modulated arc therapy (VMAT) once every 3 minutes for 10 fractions (for a total of 28-33 fractions depending on dose level) 5 days weekly (Monday-Friday) over 6-7 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for 2 years, every 6 months for 2 years, then annually thereafter.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Fox Chase Cancer Center

Principal Investigator
Joshua E. Meyer

  • Primary ID RT-155
  • Secondary IDs NCI-2020-05884, 18-1085
  • Clinicaltrials.gov ID NCT04452357