Phase II Study of First-line SBRT in Patients With Non-Metastatic Unresectable Pancreatic Cancer
- Conditions
- Pancreatic Tumor
- Interventions
- Radiation: Stereotactic Body Radiation Therapy (SBRT)Radiation: Tissue, Blood, Research Imaging (TBRI)
- Registration Number
- NCT01434550
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TBRI Subgroup: TBRI and SBRT Tissue, Blood, Research Imaging (TBRI) 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 SBRT Alone Stereotactic Body Radiation Therapy (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 TBRI Subgroup: TBRI and SBRT Stereotactic Body Radiation Therapy (SBRT) 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
- Primary Outcome Measures
Name Time Method Number of Participants With Overall Survival (OS) 36 Months 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Reduction in Size of Primary Tumor 12 Months 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.
Number of Participants With Adverse Events (AEs) 36 Months Toxicity response will be assessed and reported using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.