Aim of this study is to evaluate if low-dose radiotherapy (LDR) can intensify local effect of a chemotherapy regimen with Gem-based doublets administered sequentially with stereotactic body radiotherapy (SBRT) and to assess the safety and efficacy of this combined treatment on patients affected by locally advanced pancreatic adenocarcinoma (LAPC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, MO, Italy
RECRUITINGProgression-free survival
defined as the time from the initiation of therapy to the time of first event (local, regional or distant progression or death due to any cause). Patients without any such event at the time of data analysis will be censored at the last date they were known to be event-free. Patients with no tumor assessments after baseline will be censored at day 1
Time frame: 1 year
Toxicity(scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (v4.0))
Acute gastrointestinal toxicity is defined as adverse events occurring \<3 months after SBRT; long-term toxicity was defined as those occurring after 3 months. Toxicity is scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (v4.0)
Time frame: every 3 months, up to 1 year
Overall survival
defined as the time from the date of initiation of therapy to date of death due to any cause. Patients who is alive on the date of last follow-up were censored on that date
Time frame: 1 year
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