- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01021800
Modulation of the Immune Response in Patients With Pancreatic Tubular Adenocarcinoma (SYSTHER)
January 12, 2010 updated by: Blood Transfusion Centre of Slovenia
Interventional study of modulation of immune response in patients with pancreatic tubular adenocarcinoma after resection and gemcitabine treatment.
When included, patients are pre-treated with moderate doses of cyclophosphamide.
Then infusions of allogeneic mononuclear cells are given.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Borut Stabuc, MD PhD
- Phone Number: +38615222210
- Email: borut.stabuc@kclj.si
Study Contact Backup
- Name: Lojze Smid, MD
- Email: lojze.smid.jr@mf.uni-lj.si
Study Locations
-
-
-
Ljubljana, Slovenia, 1000
- Recruiting
- University Medical Centre Ljubljana, Department for Gastroenterolgy
-
Contact:
- Lojze Smid, MD
- Email: lojze.smid.jr@mf.uni-lj.si
-
Contact:
- Borut Stabuc, MD, PhD
- Phone Number: +38615222210
- Email: borut.stabuc@kclj.si
-
Principal Investigator:
- Borut Stabuc, MD, PhD
-
-
Participation Criteria
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.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ECOG performance status 0-2 at the time of inclusion
- Following R0 or R1 pancreatic tubular adenocarcinoma resection and adjuvant gemcitabine treatment
Exclusion Criteria:
- Pregnancy
- Less than 3 mths expected survival
- Serious comorbidity
- Age above 70 yrs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cell infusion
|
Cell infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PROGRESSION FREE SURVIVAL
Time Frame: 1 YEAR
|
1 YEAR
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
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 Major Dates
Study Start
April 1, 2009
Primary Completion (Anticipated)
December 1, 2011
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
November 27, 2009
First Submitted That Met QC Criteria
November 27, 2009
First Posted (Estimate)
November 30, 2009
Study Record Updates
Last Update Posted (Estimate)
January 13, 2010
Last Update Submitted That Met QC Criteria
January 12, 2010
Last Verified
November 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MIS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancreatic Tubular Adenocarcinoma
-
Blood Transfusion Centre of SloveniaUniversity Medical Centre LjubljanaUnknownPancreatic Tubular AdenocarcinomaSlovenia
-
The Catholic University of KoreaJanssen Korea, Ltd., KoreaCompletedEarly Gastric Adenocarcinoma | Adenocarcinoma, TubularKorea, Republic of
-
Fudan UniversityUnknownStage IA Pancreatic Adenocarcinoma | Stage IB Pancreatic Adenocarcinoma | Stage IIA Pancreatic Adenocarcinoma | Stage IIB Pancreatic AdenocarcinomaChina
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Roswell Park Cancer InstituteNot yet recruitingStage II Pancreatic Cancer AJCC v8 | Stage III Pancreatic Cancer AJCC v8 | Stage IV Pancreatic Cancer AJCC v8 | Metastatic Pancreatic Ductal Adenocarcinoma | Locally Advanced Pancreatic Ductal Adenocarcinoma | Advanced Pancreatic Ductal Adenocarcinoma | Unresectable Pancreatic Ductal Adenocarcinoma and other conditionsUnited States
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Xian-Jun YuCompletedStage IA Pancreatic Adenocarcinoma | Stage IB Pancreatic Adenocarcinoma | Stage IIA Pancreatic Adenocarcinoma | Stage IIB Pancreatic AdenocarcinomaChina
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Xian-Jun YuCompletedStage IA Pancreatic Adenocarcinoma | Stage IB Pancreatic Adenocarcinoma | Stage IIA Pancreatic Adenocarcinoma | Stage IIB Pancreatic AdenocarcinomaChina
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-
Wake Forest University Health SciencesNational Cancer Institute (NCI)RecruitingPancreas Adenocarcinoma | Locally Advanced Pancreatic Adenocarcinoma | Borderline Resectable Pancreatic AdenocarcinomaUnited States
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