Phase II Study to Evaluate Stereotactic Body Radiation Therapy For Palliative Management of Unresectable Recurrent or Residual Pancreatic or Periampullary Adenocarcinoma
This research is being done to study a method of treating pancreatic and periampullary cancer with focused radiation called Linac based Stereotactic Body Radiotherapy (SBRT). Linac based SBRT uses multiple beams of radiation to concentrate high doses of radiation within the tumor in a very precise manner. We want to establish the safety and practicality of treating pancreatic and periampullary cancers with very precisely administered high doses of radiation over a short time period. The standard treatment for cancer of the pancreas is chemotherapy, surgery or a combination of chemotherapy and radiation. Radiation therapy is a form of cancer treatment, using high energy x-rays. Although radiation and chemotherapy have beneficial effects, they are unlikely to cure the cancer completely. In this study, patients whose tumor has either returned or remained in spite of previous therapy with surgery, chemotherapy, and/or conventional radiation will receive Linac based SBRT in an attempt to stop the tumor from growing. As part of this study we will evaluate the safety and possible benefits of such therapy.
Inclusion Criteria:ï¿½Age greater than 18 years.ï¿½Karnofsky Performance Status greater than 70%.ï¿½Histologically confirmed pancreatic or periampullary adenocarcinoma; at least the majority of the histopathologic specimen must be identified as adenocarcinoma. If previously diagnosed, recurrence can be based on imaging findings of recurrence.ï¿½Either:(a)Previously underwent standard of care or protocol treatment for pancreatic or periampullary adenocarcinoma consisting of either surgical resection with neoadjuvant/adjuvant CRT for resectable disease or conventional CRT as definitive treatment for unresectable disease. These patients who have received prior radiation therapy will constitute Cohort A and will receive SBRT as 5 Gy x 5.OR (b)Previously underwent standard of care or protocol treatment for pancreatic or periampullary adenocarcinoma consisting of chemotherapy (without radiation) for unresectable disease or surgical resection with neoadjuvant/adjuvant chemotherapy (without radiation) for resectable disease. Patients who have not previously received radiation therapy will constitute Cohort B and will receive Linac based SBRT as 6.6 Gy x 5.ï¿½Disease recurrence or persistent disease at least 6 months after completing initial definitive therapy for patients who have received prior radiation and 4 months after completing initial therapy for patients who have not received radiation.ï¿½Pancreatic or periampullary tumors must be less than 8 cm in greatest axial dimension at time of treatment planning.ï¿½No active infection requiring hospitalizationï¿½Patients must have acceptable organ and marrow function.ï¿½Women who are not post-menopausal should have a negative urine or serum pregnancy test. Women of childbearing potential must agree to use adequate contraception for the duration of study participation.ï¿½Ability to understand and the willingness to sign a written informed consent document.ï¿½Life expectancy greater than 3 months.Exclusion Criteria:ï¿½Presence of metastatic disease.ï¿½Infections requiring systemic antibiotic treatment.ï¿½Unable to understand or unwilling to sign a written informed consent document.ï¿½Life expectancy less than 3 months.
If you agree to be in this study, we will ask you to do the following things:First, you must be evaluated and your scans reviewed by surgeons who are co-investigators in this study, to confirm that your tumor cannot be removed with surgery.In addition, some people may have functional imaging of their tumor performed before and after treatment using a technique called PET scanning. The PET imaging study involves visualizing the utilization of glucose (sugar) by your tumor. These studies will help us to decide if the treatments have been effective and may help us to find areas of disease that were not seen on standard imaging studies. If the PET imaging shows that cancer has spread outside of the pancreas or periampullary region (metastatic disease), you will not be a candidate for this study.Prior to radiotherapy, 1-5 gold markers will be implanted in and around your tumor. In the majority of patients, these markers are placed endoscopically. This procedure involves being lightly sedated and having an endoscope passed down your throat into the stomach or duodenum. Using an ultrasound device to visualize the tumor, the markers are implanted directly into your tumor with a small needle. Occasionally, these markers cannot be placed safely by either of these methods. In the event the attending interventional radiologist does not think that it is possible to place these markers safely by this method, you may choose to undergo laparoscopic surgery (minimally invasive surgery done through narrow tubes) under general anesthesia, for the placement of several small markers that will be imbedded into the tissues in and around your periampullary tumor. Three small incisions in your abdomen are necessary to perform this procedure. Following surgery, you will be given pain medications for 2-5 days to minimize the pain you may experience. It is anticipated that this procedure can be done on an outpatient basis, although it may be necessary in some circumstances to hospitalize you overnight. After the markers have been placed, a CT scan called simulation scan will be done in the Radiation Oncology Department. A plastic mold, called a cradle, will also be made to help immobilize your back, chest and abdomen during radiation.About one to two weeks after the simulation scan, you will be treated with Linac based SBRT. Each radiation treatment will last about 40 minutes. The amount of radiation you will receive will be individualized depending on whether you have had previous radiation therapy. During treatment you will be expected simply to lie reasonably still, after which you can leave the hospital and participate in your normal activities.
09/20/2014 04:03 AM