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Phase II Study of First-line SBRT in Patients With Non-Metastatic Unresectable Pancreatic Cancer

NCT01434550 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-02-23

No results posted yet for this study

Summary

The purpose of this study is to see if SBRT will be a better way to treat pancreas cancer and to find out what effects, good and/or bad, this treatment will have on participants and their cancer.

Conditions

  • Pancreatic Tumor

Interventions

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

Everyone who takes part in this study will receive SBRT. After making an individual radiation plan for each participant, they will receive 5 days of radiation to the pancreas. Participants will have follow-up visits with blood tests one month after the end of SBRT and then every 3 months for 3 years. They will also have CT scans (chest and pancreas) and FDG PET/CT (body) at 1 month and then at 3, 6, 9 and 12 months.

RADIATION

Tissue, Blood, Research Imaging (TBRI)

Post-SBRT procedures (day 1, 3, 5 of SBRT, and 4 weeks after) A) Endoscopic or CT guided biopsy of treated pancreatic cancer to assess 1. Necrosis/apoptosis 2. Lymphocyte infiltrate and antigen presenting cells B) Imaging to evaluate cell death (day 1, 3, 5 of SBRT, and 4 weeks after) 1\. Aposense-PET imaging

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Ravi Shridhar, M.D., Ph.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-08-31
Completion
2015-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01434550 on ClinicalTrials.gov