Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to find the better radiation therapy between intraoperative radiotherapy (IORT) and concurrent chemoradiotherapy (CCRT).


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02981641
Study type Interventional
Source Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact Jianwei Zhang, Ph.D.
Phone +8613581841816
Email panchutong@163.com
Status Recruiting
Phase N/A
Start date December 2015
Completion date December 2018

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03252808 - Phase I Study of TBI-1401(HF10) Plus Chemotherapy in Patients With Unresectable Pancreatic Cancer. Phase 1
Suspended NCT03697564 - Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial). Phase 2
Recruiting NCT05642962 - Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC) Phase 1/Phase 2
Recruiting NCT06017284 - Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer Phase 3
Recruiting NCT04674956 - A Prospective, Randomized, Double-blinded, Multi-center Clinical Trial to Evaluate the Efficiency and Safety of Anti-PD1 Antibody (Camrelizumab) Combined With Paclitaxel(Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Cancer Phase 3
Completed NCT03412799 - Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer Phase 1
Completed NCT04181645 - SHR- 1210 Combined With Paclitaxel (Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Cancer N/A
Withdrawn NCT04852367 - PanDox: Targeted Doxorubicin in Pancreatic Tumours Phase 1
Recruiting NCT04150042 - SHARON: A Clinical Trial for Metastatic Cancer With a BRCA or PALB2 Mutation Using Chemotherapy and Patients' Own Stem Cells Phase 1
Recruiting NCT04628806 - Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells
Completed NCT04953962 - Study of CBP501/Cisplatin/Nivolumab Combinations in Advanced Pancreatic Cancer Phase 2
Recruiting NCT05254171 - Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer Phase 2/Phase 3
Recruiting NCT03236883 - Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer Phase 1
Recruiting NCT04406831 - The Role of MicroRNA in the Diagnosis, Prognosis and Response to Treatment in Pancreatic Cancer
No longer available NCT04137822 - Expanded Access Program Using IMM-101 for Patients With Advanced Pancreatic Cancer