Translational Research on Locally Advanced Pancreatic Adenocarcinoma
TRLAPA
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to find the best neoadjuvant therapy for pancreatic adenocarcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pancreatic-cancer
Started Jul 2015
Typical duration for not_applicable pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 22, 2016
CompletedFirst Posted
Study publicly available on registry
January 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJanuary 4, 2017
December 1, 2016
3.4 years
December 22, 2016
December 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
translational resection rate
half a year
Secondary Outcomes (2)
progression-free survival
2 years
Local control rate
2 years
Study Arms (2)
Concurrent chemoradiotherapy(CCRT) Group
EXPERIMENTALConcurrent 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)
Chemotherapy Group
EXPERIMENTALChemotherapy (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)
Interventions
the 2 arms have different orders of treatment,participants in arm A accept concurrent chemoradiotherapy at first and then accept evalution for surgery.In arm B,participants accept concurrent chemoradiotherapy at first and then accept evalution for surgery.
Eligibility Criteria
You may qualify if:
- have cytologic or pathological proof of pancreatic adenocarcinoma without surgery contraindication score of ECOG is between 0 and 1 evaluation of CT is unresectable
You may not qualify if:
- metastatic pancreatc adenocarcinoma malignant tumors history allergic to 5-FU have difficulty in swallowing joined other clinical trails cardiac and renal disease active infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Institute and Hospital ,China Academy of Medical Sciences
Beijing, Beijing Municipality, 10021, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chengfeng Wang, B.A.
Investigator CancerIHCAMS
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 pancreatic and gastric surgery
Study Record Dates
First Submitted
December 22, 2016
First Posted
January 4, 2017
Study Start
July 1, 2015
Primary Completion
December 1, 2018
Study Completion
December 1, 2019
Last Updated
January 4, 2017
Record last verified: 2016-12