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2015-07
2018-12
2019-12
40
NCT03009253
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
INTERVENTIONAL
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-12-22 | N/A | 2016-12-31 |
2016-12-31 | N/A | 2017-01-04 |
2017-01-04 | N/A | 2016-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Concurrent chemoradiotherapy(CCRT) Group Concurrent chemoradiotherapy (Total dose: 30-40 Gy; Single dose: 3-4 Gy; Frequency: 10; S-1 orally (80 mg/m2/d),2 weeks) Followed by chemotherapy: Gemcitabine(GEM), 1000 mg/m2 ,Day 1,8 ); taking S-1 orally (80 mg/m2/d, bid on Day 1-14, Q21d, 3 cycles) | OTHER: order of treatment
|
| EXPERIMENTAL: Chemotherapy Group Chemotherapy (Gemcitabine(GEM), 1000 mg/m2 ,Day 1,8 ); taking S-1 orally (80 mg/m2/d, bid on Day 1-14, Q21d, 3 cycles) Followed by Concurrent chemoradiotherapy: (Total dose: 30-40 Gy; Single dose: 3-4 Gy; Frequency: 10; S-1 orally (80 mg/m2/d),2 weeks) | OTHER: order of treatment
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| translational resection rate | half a year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| progression-free survival | PFS | 2 years |
| Local control rate | LCR | 2 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Xu Che, M.D Phone Number: 8610-87787120 Email: xu.che@hotmail.com |
Study Contact Backup Name: Yunmian Chu, M.D. Phone Number: +8618101333727 Email: chuyunmian@foxmail.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
