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Protocol No. RO12210

Principal Investigator Bassetti, Michael

Phase I

Age Group Adult

Scope Local

Sponsor Type Institutional

Title A phase Ia-Ib dose-escalation study evaluating safety and efficacy of neoadjuvant stereotactic body radiotherapy (SBRT) with concomitant capecitabine-based chemotherapy (ChT) for resectable pancreatic adenocarcinoma

Objective The purpose of this study is to identify the highest safe dose of SBRT when given with capecitabine chemotherapy prior to performing surgery for patients with resectable pancreatic cancer. We want to find out the effects (good and bad) of treatment with this approach. In this study, the radiation dose is being carefully and gradually increased to identify the highest safe dose. For any single subject, the dose of radiation received during each of the five treatments will stay the same. The dose of radiation that you will receive will depend on how many subjects have participated in this study prior to your participation and their tolerance of treatment. Your physician will inform you of what your daily radiation dose will be.

The reason to test higher radiation doses is because it is possible that higher doses will improve the control of the cancer. But at the same time, raising the radiation dose needs to be done gradually, as in this study, to minimize the risk of severe side effects. Once the highest safe dose of SBRT has been identified, we will then go on to use this dose for future patients in future studies of resectable pancreatic cancer.

Treatment If you choose to participate in this study, you will be treated with SBRT. You will receive one treatment every other day for a total of 5 treatments within 1½ to 2 weeks. In addition to the SBRT, you will also receive chemotherapy with an oral drug(pill) named capecitabine, which is routinely used in combination with standard radiotherapy.

Description This study is testing a new way to give radiotherapy in combination with chemotherapy before surgery for patients with early stage, resectable pancreatic cancer. In this study a newer radiation treatment method called Stereotactic Body Radiation Therapy (SBRT) will be used along with standard of care chemotherapy prior to surgery. SBRT is a method of delivering radiation that allows the doctor to deliver a high dose of radiation to a very carefully targeted area such as the pancreas. The radiation and chemotherapy will be completed before surgery. Radiation and chemotherapy will occur over a two week period. It is anticipated that surgery will occur 3-6 weeks after you complete the chemoradiation treatment. Click here for more info

Key Eligibility
  • Confirmed diagnosis of carcinoma of exocrine pancreatic head amenable to surgical resection.
  • Patients must not have any evidence of regional or distant metastatic disease based on CT scan of the chest/abdomen/pelvis and diagnostic laparoscopy.
  • Patients must not have had any prior treatment for pancreatic cancer in the last 5 years.

  • Applicable Disease Sites Pancreas

    Therapies Involved Cytotoxic Chemotherapy; Radiotherapy

    Drugs Involved Capecitabine; Xeloda (Capecitabine)

    Status Open

    Participating Institutions UW Hospital and Clinics