Dose Escalation Study of CyberKnife® SBRT Boost for Patients With Unresectable Locally Advanced Pancreatic Cancer

Official Title

Phase I Time-to-Event Continual Reassessment (TITE-CRM) Dose Escalation Trial of CyberKnife® Stereotactic Body Radiation Therapy (SBRT) Boost With Concurrent Chemoradiotherapy for Patients With Unresectable Locally Advanced Pancreatic Cancer


Currently the standard treatment for locally advanced, unresectable pancreatic cancer consists either of chemotherapy by itself or a combination of chemotherapy plus radiation therapy or no treatment at all. Unfortunately, no treatment thus far has been able to provide patients with a consistent chance for a cure although there are rare patients who will live for many years after treatment. For most patients the chemotherapy or chemotherapy plus radiation will maintain or improve quality of life by keeping the cancer under control for a period of time. Approximately 25-30% of patients with early pancreatic cancer who are able to have the cancer completely removed surgically will live beyond 5 years and will be considered cured. This tells us that aggressive treatment directed at the tumour in the pancreas can lead to cure. For the majority of patients who can not have an operation, giving more radiation as part of the treatment may be a strategy that results in better control of the tumour in the pancreas which may or may not result in patients living longer. The purpose of this study is to test the safety of adding a higher dose (a "boost" dose) of radiation using a radiation unit called CyberKnife when combined with standard chemotherapy and radiation for patients with locally advanced, unresectable pancreatic cancer. Participants on this study will receive a 'boost' dose of radiation which consists of 3 treatments over 1 week. The participants will then receive the standard of care treatment of chemotherapy and standard radiation therapy over a 5 week period, which will be followed by the conventional 20 weeks of chemotherapy alone. The participants will then be followed for progression of disease and toxicity related to the boost treatment for up to 5 years.

Trial Description

Primary Outcome:

  • Toxicity defined as grade 3 or 4 gastro-intestinal or other non-haematological toxicity
Secondary Outcome:
  • CT scans will measure tumour response
  • CyberKnife radiation dose measured in Gy delivered to the tumour and surrounding organs vs. the frequency of grade 3-4 toxicity defined by CTCAE v4.0
Stereotactic body radiation therapy (SBRT) is a minimally invasive treatment technique that allows for ultra-high doses of radiation to be delivered to small areas with precision not previously possible using older equipment. The CyberKnife® Robotic Radiosurgery System (Accuray, Sunnyvale California, USA) is a radiation unit specifically designed to focus beams of radiation accurately anywhere in the body. It is able to track, detect and correct for any tumour movement during treatment by using a sophisticated image guidance system.

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