Pancreatic Cancer Stage IV Clinical Trial
Official title:
Intraoperative Radiotherapy (IORT) Versus Concurrent Chemoradiotherapy (CCRT) for Pancreatic Cancer
The purpose of this study is to find the better radiation therapy between intraoperative radiotherapy (IORT) and concurrent chemoradiotherapy (CCRT).
The trial is funded by National High-tech R&D Program (863 Program). The trial is prepared
to be registered on the clinicaltrail.gov.
Quality assurance plan: Every participant is enrolled or excluded by two practiced
investigators. And two investigators participated in all steps of the trail, including the
record of the data, and the investigators will compare the data. If the data is consistent,
the investigators would record the data; if not, the data would be checked and decided by
the two investigators. All the steps and data are site monitored and audited by the workers
of research and financial department of The First Affiliated Hospital of China Medical
University Data check: The investigators compare data entered into the registry against
predefined rules for range or consistency with other data fields in the registry. Source
data verification to assess the accuracy, completeness, or representativeness of registry
data by comparing the data to external data sources, including medical records and
electronic case report forms. Data dictionary that contains detailed descriptions of each
variable used by the registry, including the source of the variable, coding information, and
normal ranges if relevant. Standard Operating Procedures to address registry operations and
analysis activities, such as participants recruitment, data collection, data management,
data analysis, reporting for adverse events, and change management. All registry operations
would be done according to specific steps, and by two practiced investigators. Sample size
assessment to specify the number of participants or participant years necessary to
demonstrate an effect. According to the formula to differ advantages and disadvantages, the
investigators need at least 100 participants to take part in the trail. The investigators
can recruit about 120 participants every year according to previous experiences, so the
investigators should recruit at least for one years.
Plan for missing data: The investigators would collect as much data as possible, and the
investigators exclude the participants who cannot cooperate on recruitment. And the
investigators manage situations according to statistical principles where variables are
reported as missing, unavailable, "non-reported," uninterpretable, or considered missing
because of data inconsistency or out-of-range results.
Statistical analysis plan: Kaplan-Meier method would be used to analyze the difference of
survival time between the two groups, and the local control rate of the two groups would be
compared by chi square test. Statistical analyses would be performed by using IBM SPSS
Statistics(version 20; IBM, Chicago, USA). The level of significance is defined as P < 0.05.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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