Pancreatic Cancer Clinical Trial
Official title:
An Open-Labeled, Randomized Phase II Trial of Adjuvant Chemotherapy in Combination With Stereotactic Body Radiation Therapy (SBRT) Versus Adjuvant Chemotherapy Alone for Patients After Radical Resection of Pancreatic Cancer With Advanced Stages (T3 or N1)
Pancreatic cancer is one of the deadliest tumor types of the alimentary system. Resection is
the only curable method to treat pancreatic cancer. However, even if radical resection is
achieved, the 5-year survival rate is still low because of tumor recurrence. It's reported
adjuvant radiation can prolong survival and improve quality of life after surgery. For R0
(microscopic negative margin) resection patients with advanced stages (T3 or N1), the value
of adjuvant radiation is still in debate. It's warranted to explore the role of adjuvant
radiation for patients after radical resection of pancreatic cancer with advanced stages (T3
or N1) in large, prospective, and randomized cohorts.
The application of Stereotactic Body Radiation Therapy (SBRT) makes radiation less harmful
and more flexible. It is hoped that adjuvant SBRT may benefit post-operative patients with
advanced stages and one day adjuvant SBRT combined with chemotherapy become the standard of
care for pancreatic cancer patients.
Pancreatic cancer is one of the deadliest tumor types of the alimentary system. Despite of
the dramatic progress of diagnostic methods and surgical technics, the overall 5-year
survival is still around 5%. Resection is the only curable method to treat pancreatic
cancer, although only a small proportion of patients are eligible for operation. However,
even if radical resection is achieved, the 5-year survival rate is only 15-20%. The main
cause of death is tumor recurrence, which is as high as 50-70% in 3 years after operation.
By now, it is widely accepted that pancreatic cancer is a systemic disease. Systemic
treatments are recommended in neoadjuvant and adjuvant manners. It's reported adjuvant
radiation can prolong survival and improve quality of life after surgery, especially for
patients who undergo a R1 (microscopic positive margin) and R2 (macroscopic positive margin)
resection. For R0 (microscopic negative margin) resection patients with advanced stages (T3
or N1), the value of adjuvant radiation is still in debate. Some argues adjuvant radiation
after radical resection makes no effect on preventing local recurrence and metastasis but
may impair patients' quality of life and overall survival. On the contrary, some other
researchers draw the conclusion that adjuvant radiation may facilitate the local control of
tumor recurrence in small cohorts. It's warranted to explore the role of adjuvant radiation
for patients after radical resection of pancreatic cancer with advanced stages (T3 or N1) in
large, prospective, and randomized cohorts.
Traditionally, radiation may take more than one month to deliver and the dosage is
restricted to prevent damage to surrounding tissues. The size effects and duration impair
patients' compliance. Recently, the application of Stereotactic Body Radiation Therapy
(SBRT) makes radiation less harmful and more flexible. The advantages of SBRT are higher
dosage of radiation, less damage to surrounding organs, and significant reduce of duration.
To our knowledge, there is no big randomized clinical trial to evaluate the value of SBRT
for patients after radical resection of pancreatic cancer with advanced stages (T3 or N1).
It is hoped that adjuvant SBRT may benefit post-operative patients with advanced stages and
one day adjuvant SBRT combined with chemotherapy become the standard of care for pancreatic
cancer patients.
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