IORT Followed by CCRT or SBRT for Locally Advanced Pancreatic Cancer (IFCSLAPC)
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|ClinicalTrials.gov Identifier: NCT02734680|
Recruitment Status : Recruiting
First Posted : April 12, 2016
Last Update Posted : April 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Radiation: Concurrent chemoradiotherapy(CCRT) Radiation: Stereotactic Radiotherapy(SBRT) Drug: S-1||Not Applicable|
The trial is funded by Cancer Foundation of China. 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 70 participants to take part in the trail. The investigators can recruit about 35 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Intraoperative Radiotherapy(IORT) Followed by Concurrent Chemoradiotherapy(CCRT) or Stereotactic Radiotherapy(SBRT) for Locally Advanced Pancreatic Cancer|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2019|
Experimental: Concurrent chemoradiotherapy(CCRT) Group
Concurrent chemoradiotherapy(CCRT) (Total dose: 46 Gy; Single dose: 2 Gy; Frequency: 23; Gemcitabine(GEM), 300 mg/m2 weekly); Followed by taking S-1 orally (40 mg/m2, bid on Day 1-28, Q42d)
Radiation: Concurrent chemoradiotherapy(CCRT)
Radiation and take gemcitabine(GEM)
Other Name: Concurrent chemoradiotherapy
Taking S-1 orally after radiation
Other Name: S-1 orally
Experimental: Stereotactic Radiotherapy(SBRT) Group
Stereotactic Radiotherapy(SBRT) (Total dose: 45 Gy; Single dose: 3 Gy; Frequency: 15) Followed by taking S-1 orally (40 mg/m2, bid on Day 1-28, Q42d)
Radiation: Stereotactic Radiotherapy(SBRT)
Stereotactic Radiotherapy(SBRT) (total dose: 45 Gy; single dose: 3 Gy; Frequency:15)
Other Name: Stereotactic Radiotherapy
Taking S-1 orally after radiation
Other Name: S-1 orally
- Overal survival [ Time Frame: 2 years ]OS
- Disease-specific survival [ Time Frame: 2 years ]DSS
- Progression-free survival [ Time Frame: 2 years ]PFS
- Local control rate [ Time Frame: 2 years ]LCR
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734680
|Contact: Yingtai Chen, PhDfirstname.lastname@example.org|
|Contact: Shuisheng Zhang, M.D.||+email@example.com|
|National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College||Recruiting|
|Beijing, Beijing, China, 100021|
|Contact: Yingtai Chen, PhD +8618600258827 firstname.lastname@example.org|
|Contact: Shuisheng Zhang, M.D +18001302322 email@example.com|
|Principal Investigator: Chengfeng Wang, B.A.|
|Principal Investigator:||Chengfeng Wang, B.A.||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|