IORT Followed by CCRT or SBRT for Locally Advanced Pancreatic Cancer
IFCSLAPC
Intraoperative Radiotherapy(IORT) Followed by Concurrent Chemoradiotherapy(CCRT) or Stereotactic Radiotherapy(SBRT) for Locally Advanced Pancreatic Cancer
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pancreatic-cancer
Started Feb 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 7, 2016
CompletedFirst Posted
Study publicly available on registry
April 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedApril 11, 2017
April 1, 2017
2 years
April 7, 2016
April 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overal survival
OS
2 years
Secondary Outcomes (3)
Disease-specific survival
2 years
Progression-free survival
2 years
Local control rate
2 years
Study Arms (2)
Concurrent chemoradiotherapy(CCRT) Group
EXPERIMENTALConcurrent 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)
Stereotactic Radiotherapy(SBRT) Group
EXPERIMENTALStereotactic 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)
Interventions
Radiation and take gemcitabine(GEM)
Stereotactic Radiotherapy(SBRT) (total dose: 45 Gy; single dose: 3 Gy; Frequency:15)
Taking S-1 orally after radiation
Eligibility Criteria
You may qualify if:
- Diagnosed as locally advanced pancreatic cancer.
- Cannot be treated by surgical resection.
You may not qualify if:
- Treated by chemotherapy or radiotherapy before.
- With distant organ metastasis.
- Cannot tolerate surgery (Intraoperative radiotherapy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chengfeng Wang, B.A.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Abdominal Surgical Oncolgoy
Study Record Dates
First Submitted
April 7, 2016
First Posted
April 12, 2016
Study Start
February 1, 2016
Primary Completion
February 1, 2018
Study Completion
February 1, 2019
Last Updated
April 11, 2017
Record last verified: 2017-04