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2003-03
2010-06
2012-06
0
NCT00226746
New York Presbyterian Brooklyn Methodist Hospital
New York Presbyterian Brooklyn Methodist Hospital
INTERVENTIONAL
Efficacy Study of Gemcitabine, Paclitaxel, and Irradiation in the Treatment of Pancreatic Cancer
The purpose of this study is to find out what effects, good and bad, the chemotherapy drugs gemcitabine (Gemzar) and paclitaxel (Taxol) have in combination with twice daily radiation treatment on locally advanced pancreatic cancer.
Based on our previous experience with the use of a weekly paclitaxel dose of 60 mg/m2 and hyperfractionated radiation therapy 63.8 Gy, we are conducting this study incorporating the use of Gemcitabine at a dose level of 75 mg/m2/week in addition to our prior protocol.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2005-09-23 | N/A | 2020-09-16 |
2005-09-23 | N/A | 2020-09-18 |
2005-09-27 | N/A | 2020-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Paclitaxel and Gemcitabine Radiation Therapy: 63.80 Gy (1.1 Gy twice a day X 58 fractions), Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36. Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36. | DRUG: Paclitaxel and gemcitabine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| One-year overall survival rate | Follow up for survival will be done to know this outcome | Up to June 2010 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Occurrence of grade 3 or higher toxicity in the gastrointestinal or pulmonary | Follow up for occurrence of adverse events will be done to know this outcome | year 2010 |
| Occurrence of pathological response or shrinkage of the tumor (becomes resectable) | Follow up for tumor response will be done to know this outcome | year 2010 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
