Pancreatic Cancer Clinical Trial
Official title:
Translational Research on Locally Advanced Pancreatic Adenocarcinoma
The purpose of this study is to find the best neoadjuvant therapy for pancreatic adenocarcinoma.
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 National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences.
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 80 participants to take part in the trail.
The investigators can recruit about 20 participants every year according to previous
experiences, so the investigators should recruit at least for two 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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