EUS-guided Intratumoral Gemcitabine in Locally Advanced Unresectable Pancreatic Cancer
NCT ID: NCT01834170
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2013-04-30
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
About 40% of the patients present with advanced disease with distant metastasis, and the remaining 40% present with locally advanced unresectable cancer with the tumor invaded into surrounding major vessels. For those with locally advanced disease, systemic chemotherapy with or without radiotherapy provides palliation of the symptoms but cannot cure the disorder. Systemic chemotherapy is given through peripheral vessels.
The investigators hypothesized that direct injection of the chemotherapeutic drug into the tumor may help to boost the effect of systemic chemotherapy and radiotherapy in those with locally advanced pancreatic cancer.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intratumoral gemcitabine injection
Intratumoral injection of gemcitabine by means of endoscopic ultrasound.
Gemcitabine
Two intratumoral injections of gemcitabine under endoscopic ultrasound (EUS)-guidance at month 0 and month 3.
The patients will receive systemic chemotherapy with or without radiotherapy at the discretion of oncologist
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gemcitabine
Two intratumoral injections of gemcitabine under endoscopic ultrasound (EUS)-guidance at month 0 and month 3.
The patients will receive systemic chemotherapy with or without radiotherapy at the discretion of oncologist
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Pancreatic cancer with distant metastasis
* Unwilling to sign informed consent
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Tehran
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mehdi Mohamadnejad
Assistant Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mehdi Mohamadnejad, M.D.
Role: PRINCIPAL_INVESTIGATOR
Digestive Disease Research Center, University of Tehran/Medical sciences
Reza Malekzadeh, M.D.
Role: STUDY_CHAIR
Digestive Disease Research Center, University of Tehran/Medical Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Digestive Disease Research Center, Shariati ospital
Tehran, , Iran
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DDRC 92-1
Identifier Type: -
Identifier Source: org_study_id