EUS-guided Intratumoral Gemcitabine in Locally Advanced Unresectable Pancreatic Cancer
Primary Purpose
Pancreatic Adenocarcinoma
Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Adenocarcinoma focused on measuring Pancreatic cancer, Pancreatic adenocarcinoma, Endoscopic ultrasound
Eligibility Criteria
Inclusion Criteria:
- Patients with histologically verified pancreatic adenocarcinoma who have locally advanced unresectable tumor
Exclusion Criteria:
- Early stage resectable pancreatic cancer with the intact surrounding major vessels on imaging
- Pancreatic cancer with distant metastasis
- Unwilling to sign informed consent
Sites / Locations
- Digestive Disease Research Center, Shariati ospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intratumoral gemcitabine injection
Arm Description
Intratumoral injection of gemcitabine by means of endoscopic ultrasound.
Outcomes
Primary Outcome Measures
Number of participants with adverse events as a measure of safety and tolerability
Secondary Outcome Measures
Proportion of participants who remain alive one year after enrollment compared to the historical matched control group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01834170
Brief Title
EUS-guided Intratumoral Gemcitabine in Locally Advanced Unresectable Pancreatic Cancer
Official Title
EUS-guided Intratumoral Gemcitabine Therapy in Locally Advanced Unresectable Pancreatic Cancer: A Phase 1 Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tehran
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause of cancer death. The only effective treatment for pancreatic cancer includes surgery. However, only 20% of the patients have surgically treatable disease. Also, the 5-year survival for the surgically treated patients is only 15%.
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
In this study, gemcitabine will be injected directly into the tumor by means of endoscopic ultrasound (EUS) in the eligible patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma
Keywords
Pancreatic cancer, Pancreatic adenocarcinoma, Endoscopic ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intratumoral gemcitabine injection
Arm Type
Experimental
Arm Description
Intratumoral injection of gemcitabine by means of endoscopic ultrasound.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of participants with adverse events as a measure of safety and tolerability
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of participants who remain alive one year after enrollment compared to the historical matched control group
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with histologically verified pancreatic adenocarcinoma who have locally advanced unresectable tumor
Exclusion Criteria:
Early stage resectable pancreatic cancer with the intact surrounding major vessels on imaging
Pancreatic cancer with distant metastasis
Unwilling to sign informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehdi Mohamadnejad, M.D.
Organizational Affiliation
Digestive Disease Research Center, University of Tehran/Medical sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Reza Malekzadeh, M.D.
Organizational Affiliation
Digestive Disease Research Center, University of Tehran/Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Digestive Disease Research Center, Shariati ospital
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
EUS-guided Intratumoral Gemcitabine in Locally Advanced Unresectable Pancreatic Cancer
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