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.
View this trial on ClinicalTrials.gov
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