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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
Sponsor:
Information provided by (Responsible Party):
Chengfeng Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary:
The purpose of this study is to find the best model of combination of intraoperative radiotherapy(IORT) and postoperative radiochemotherapy for pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: Concurrent chemoradiotherapy(CCRT) Radiation: Stereotactic Radiotherapy(SBRT) Drug: S-1 Not Applicable

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Drug: S-1
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

Drug: S-1
Taking S-1 orally after radiation
Other Name: S-1 orally




Primary Outcome Measures :
  1. Overal survival [ Time Frame: 2 years ]
    OS


Secondary Outcome Measures :
  1. Disease-specific survival [ Time Frame: 2 years ]
    DSS

  2. Progression-free survival [ Time Frame: 2 years ]
    PFS

  3. Local control rate [ Time Frame: 2 years ]
    LCR



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed as locally advanced pancreatic cancer.
  • Cannot be treated by surgical resection.

Exclusion Criteria:

  • Treated by chemotherapy or radiotherapy before.
  • With distant organ metastasis.
  • Cannot tolerate surgery (Intraoperative radiotherapy)

Information from the National Library of Medicine

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


Contacts
Contact: Yingtai Chen, PhD +8618600258827 yingtai.chen@hotmail.com
Contact: Shuisheng Zhang, M.D. +8618001302322 thelifeofwater@126.com

Locations
China, Beijing
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    yingtai.chen@hotmail.com   
Contact: Shuisheng Zhang, M.D    +18001302322    thelifeofwater@126.com   
Principal Investigator: Chengfeng Wang, B.A.         
Sponsors and Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Chengfeng Wang, B.A. Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Responsible Party: Chengfeng Wang, Director of Department of Abdominal Surgical Oncolgoy, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02734680     History of Changes
Other Study ID Numbers: LC2015L11
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Chengfeng Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences:
Pancreatic cancer
Intraoperative radiotherapy(IORT)
Postoperative radiochemotherapy

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases