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Pancrelipase

Pancreatin

Six patients will be asked to be part of a subgroup called TBRI (Tissue, Blood, Research Imaging). In this subgroup, we want to study if there is early death of tumor cells from the treatment by looking at the tumor using PET/CT scans and biopsies, and by testing the participant's body's white blood cells taken by a procedure called leukapheresis.

Participants do not have to take part in the TBRI subgroup to get treatment on this study with SBRT.

SBRT:

1. 30 Gy in 5 fractions to pancreatic tumor
2. 50 Gy in 5 daily consecutive fractions unresectable portion and avoiding bowel, stomach, and duodenum

1. 30 Gy in 5 fractions to pancreatic tumor
2. 50 Gy in 5 daily consecutive fractions unresectable portion and avoiding bowel, stomach, and duodenum

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.

Stereotactic Body Radiation Therapy (SBRT)

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

Tissue, Blood, Research Imaging (TBRI)

Ravi Shridhar, M.D., Ph.D.

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.

The standard treatment for cancer of the pancreas is surgery (if possible), external beam radiation therapy and/or chemotherapy. These standard treatments are not a cure and often extend life by just a few months. Recently, a new approach has been developed, called stereotactic body radiation therapy (SBRT). Based on the results of earlier studies using SBRT, the study doctors at Moffitt feel this is a reasonable alternative to the standard treatment for your disease.

Stereotactic body radiation therapy (SBRT) delivers high radiation doses to the tumor every day for 5 days which gives the usual 5-6 week course of radiation in less than a week. It has also been shown to have much less side effects.

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 you and your cancer.

Six patients will be asked to be part of a subgroup called TBRI (Tissue, Blood, Research Imaging). In this subgroup, the investigators want to study if there is early death of tumor cells from the treatment by looking at the tumor using PET/CT scans and biopsies, and by testing your body's white blood cells taken by a procedure called leukapheresis. You do not have to take part in the TBRI subgroup to get treatment on this study with SBRT.

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

Phase II Study of First-line Stereotactic Body Radiation Therapy (SBRT) in Patients With Non-Metastatic Unresectable Pancreatic Cancer

Patients will be followed for 36 months to determine overall survival even after completion of the experimental portion of the protocol. Patients will be followed every 3 months. All patients will be referred for chemotherapy at the completion of radiation.

Patients will undergo 64 slice helical computed tomography (CT) scan and feeding (FDG) pressure equalizing tube (PET)-CT scan pretreatment and at the conclusion of the study which will be separated by a 5 week time span. Subsequent helical CT and FDG PET-CT scans will be performed at 3, 6, 9 and 12 months with CA 19-9 levels. The Response Evaluation Criteria In Solid Tumors (RECIST) criteria will be used to measure clinical response. Time to local and distant disease progression will also be measured.

Toxicity response will be assessed and reported using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase II Study of First-line SBRT in Patients With Non-Metastatic Unresectable Pancreatic Cancer	NCT01434550	Pancreatic Tumo...	Stereotactic Bo... Tissue, Blood, ...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Phase II Study of First-line SBRT in Patients With Non-Metastatic Unresectable Pancreatic Cancer	NCT01434550	Pancreatic Tumo...	Stereotactic Bo... Tissue, Blood, ...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

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