Stereotactic Body Radiation + Chemotherapy for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
Pancreatic cancer, most commonly adenocarcinoma, is the fourth leading cause of cancer death in the United States. The mainstay of management centers on surgical resection (if resectable) and although low (15% to 20%), resectability rates are associated with dismal survival. An estimated 80% to 85% of the patients recur after surgical resection, leading to a median survival of 20 to 24 months and potentially even less depending on lymph nodal involvement or positive margins. The rationale for utilizing neoadjuvant therapy, commonly fluoropyrimidine-based or gemcitabine based chemotherapy or Chemoradiotherapy (CRT), involves possibly down staging borderline resectable and unresectable patients, potentially making them resectable candidates.This randomized phase II trial will study how well hypofractionated stereotactic body radiation therapy (SBRT) and fluorouracil or capecitabine with or without zoledronic acid work in treating participants with pancreatic cancer that has spread to nearby tissue or lymph nodes. Hypofractionated stereotactic body radiation therapy is a specialized radiation therapy that sends higher doses of x-rays over a shorter period of time directly to the tumor using smaller doses over several days which may cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Zoledronic acid is used in cancer patients to reduce cancer symptoms and may make tumor cells more sensitive to radiation. Giving hypofractionated stereotactic body radiation therapy and fluorouracil or capecitabine with or without zoledronic acid may work better in treating pancreatic cancer.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently taking Zometa, you must stop at least 3 weeks before starting the trial treatment.
Is the combination of Stereotactic Body Radiation and Chemotherapy safe for humans?
Capecitabine (Xeloda) and 5-fluorouracil (5-FU) have been used in various cancer treatments, including colorectal and breast cancer, with generally manageable side effects. Studies have shown that these drugs, when used with radiation therapy, are well tolerated, although the specific safety of the combination with Stereotactic Body Radiation Therapy for pancreatic cancer is not detailed in the available research.12345
How is the treatment of Stereotactic Body Radiation + Chemotherapy for Pancreatic Cancer different from other treatments?
This treatment combines stereotactic body radiation therapy (SBRT), which delivers high doses of radiation precisely to the tumor, with chemotherapy drugs like Capecitabine and Fluorouracil. This approach aims to improve local control and survival rates by targeting the tumor more effectively while sparing surrounding healthy tissue, which is different from traditional chemotherapy or radiation methods that may affect more of the surrounding area.678910
What data supports the effectiveness of the treatment Stereotactic Body Radiation + Chemotherapy for Pancreatic Cancer?
Research indicates that combining fluorouracil (5-FU) with radiation therapy can improve outcomes in gastrointestinal cancers, including pancreatic cancer. Capecitabine, an oral form of 5-FU, has shown promise in enhancing the effects of radiation therapy, potentially leading to better tumor control and increased survival.1112131415
Who Is on the Research Team?
Chi Lin, MD, PhD
Principal Investigator
University of Nebraska
Are You a Good Fit for This Trial?
This trial is for adults with locally advanced pancreatic cancer that hasn't spread far. They should have assessable disease, no recent chemo for other cancers, and their major organs must function well. It's not for those with allergies to Zometa, serious heart issues, pregnant or nursing women, certain prior cancers unless cured over 5 years ago, active severe gastrointestinal problems, HIV infection or liver insufficiency.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Treatment
Patients receive zoledronic acid IV over no less than 15 minutes 1 week prior to radiation therapy
Radiation and Chemotherapy
Patients undergo hypofractionated stereotactic body radiation therapy in 5 fractions on days 1-5 and receive fluorouracil IV or capecitabine PO for 4 weeks
Surgery
Patients undergo surgery 6-8 weeks after completion of radiation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Capecitabine
- Fluorouracil
- Stereotactic Body Radiation Therapy
- Zoledronic Acid
Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Chi Lin, MD, PhD
Lead Sponsor
University of Nebraska
Lead Sponsor
National Cancer Institute (NCI)
Collaborator