This research study is for people who have pancreas cancer for which surgery is not recommended. Potential patients must have already received several months of chemotherapy before they are eligible for this study and there will not have been any detectable spread of their tumor on imaging studies following this chemotherapy course.
In this study the investigators want to find out more about the efficacy of giving higher doses of radiation with concurrent chemotherapy in controlling unresectable pancreas cancers than are used in either the pre-operative or post-operative setting. The investigators will assess acute and late side effects (problems and symptoms) of radiation therapy given at these higher doses of radiation (dose escalated) following full dose chemotherapy given before the radiation and with concurrent chemotherapy for pancreas cancer. Radiation therapy is given in higher doses that are limited by the proximity of normal organs to the radiation dose distribution to improve the likelihood of controlling the tumor in the pancreas while minimizing the risk of radiation injury to these organs. There are two chemotherapy drugs, Capecitabine is an oral drug taken twice per day on the same day that radiation therapy is given and Gemcitabine is an intravenous drug given once per week, during radiation therapy. Everyone in this study will have already received chemotherapy alone first. Everyone in this study will receive radiation therapy and concurrent chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Radiation therapy dose escalation to an MR-defined gross tumor volume (GTV) of up to 69.75 Gy at 2.25 Gy per fraction.
Gemcitabine 400mg/m\^2 IV weekly x 6 doses. Capecitabine 825 mg/m\^2 by mouth twice daily Monday-Friday on days of radiation use 500 mg tablets.
Froedtert Hospital
Milwaukee, Wisconsin, United States
Overall Survival
This measure will be the number of subjects alive at one and two years following the end of radiation treatment, up to two years and seven weeks.
Time frame: 1 and 2 years following up to 7 weeks of radiation treatment
Radiographic Response
Number of participants treated with the proposed dose escalation achieving CR, PR, or SD measured by RECIST 1.1 criteria from magnetic resonance imaging (MRI), positron emission tomography (PET) or computed tomography (SC) scans.
Time frame: Baseline and 1 year
Serum Cancer Antigen 19-9 (CA19-9)
This measure will be the mean serum activity of CA19-9 in units/mL.
Time frame: Baseline and 1 year
Serum Carcinoembryonic Antigen (CEA)
This measure will be the mean serum concentration of CEA in ng/mL.
Time frame: Baseline and 1 year
Radiation Induced Toxicity
This measure will be the number of subjects experiencing a serious adverse event or grade three or higher non-serious adverse event by CTCAE v4.03 criteria that is definitely, likely, or possibly attributable to the radiation therapy.
Time frame: 3 months post treatment
SMAD 4 Expression
This measure will be the number of participants whose tumor biopsy is positive for the presence of SMAD 4 protein.
Time frame: Baseline
Progression Free Survival
This measure will be the number of subjects achieving a CR or PR or maintaining SD by RECIST 1.1 criteria one and two years following the end of radiation treatment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 1 and 2 years
Efficacy of Dose Escalation
This measure is the change from baseline of gross tumor volume for participants achieving a complete response (CR) or partial response (PR) or maintaining stable disease (SD) by RECIST 1.1 criteria.
Time frame: Baseline and 1 year