Suspended
Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer
What is being tested
Gemcitabine
+ Abraxane
+ Radiation Therapy
DrugRadiation
Who is being recruted
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Endocrine System Diseases
Over 18 Years
+14 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1 & 2
Interventional
Study Start: September 2012
Summary
Principal SponsorOlugbenga Olowokure
Last updated: October 26, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.The long term goal is to improve survival of patients with unresectable pancreatic cancer. Additional potential benefits include increased probability of local control and decreased distant metastases.
Principal SponsorOlugbenga Olowokure
Last updated: October 26, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
3 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Digestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasmsNeoplasms by SitePancreatic DiseasesPancreatic Neoplasms
Criteria
7 inclusion criteria required to participate
Adequate labs
All disease must be encompassed within a radiotherapy portal
ECOG performance status 0- 2
Histologically or cytologically proven carcinoma of the pancreas that is locally advanced
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7 exclusion criteria prevent from participating
Neuroendocrine tumors of the pancreas
Patient has known active infection with HIV, hepatitis C or hepatitis B
Patient has metastatic disease on radiological staging
Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalPatients will receive 2 cycles of gemcitabine and abraxane prior to the start of chemoradiation. Chemoradiation will commence 2 week after the completion of second cycle of gemcitabine/abraxane. Patients will receive an additional 2 cycles of gemcitabine and abraxane to start 2-4 weeks after the completion of chemoradiation. After the last two cycles of chemotherapy, if well tolerated with continued tumor response additional cycles of chemotherapy may be given.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
SuspendedOne Study Center