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Sponsored by: |
University of Florida |
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Information provided by: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00763516 |
Chemotherapy and Radiation Combination
Followed by:
Surgery - total resection of primary tumor and regional lymph nodes
Followed by:
Gemcitabine (Gemzar®) 1,000 mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 18 total doses
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Radiation: Proton Therapy, Capecitabine, Gemcitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study Using Neoadjuvant Proton Beam Radiation Therapy and Chemotherapy for Marginally Resectable Carcinoma of the Pancreas |
Estimated Enrollment: | 46 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2018 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Proton Therapy and Chemotherapy: Experimental
Gemcitabine (Gemzar®) 1,000 mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 18 total doses |
Radiation: Proton Therapy, Capecitabine, Gemcitabine
Gemcitabine (Gemzar®) 1,000 mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 18 total doses |
Neoadjuvant Chemotherapy Capecitabine (Xeloda®) 1,000 mg PO BID (approximately Q 12 hours) 5 days/week (M-F) starting day 1 of RT to end of RT; on radiation days only*
Proton RT Gross tumor 50.4 CGE in 28 fractions at 1.8 CGE per daily fraction over 6 weeks
↓6weeks
Surgery Gross total resection of primary tumor and regional lymph nodes
↓ 10-42 up to 56 days
Adjuvant Chemotherapy Gemcitabine (Gemzar®) 1,000 mg/m2 IV over 30 min on days 1, 8, and 15 of each 28 day cycle for 6 total cycles (18 doses)*
* required PPI and Imodium per section 6.3.1*
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Required pretreatment laboratory parameters:
Exclusion Criteria:
Contact: Amanda D Prince, RN | (904) 588-1298 | aprince@floridaproton.org |
Contact: Cindy L Carroll | (904) 588-1288 | ccarroll@floridaproton.org |
United States, Florida | |
University of Florida Proton Therapy Institute | Recruiting |
Jacksonville, Florida, United States, 32206 | |
Contact: Amanda D Prince, RN 904-588-1298 aprince@floridaproton.org | |
Contact: Cindy L Carroll (904) 588-1288 ccarroll@floridaproton.org |
Principal Investigator: | Felicia E Snead, MD | University of Florida Proton Therapy Institute |
Responsible Party: | University of Florida Proton Therapy Institute ( Felicia Snead, MD ) |
Study ID Numbers: | UFPTI 0704-PC02 |
Study First Received: | September 30, 2008 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00763516 |
Health Authority: | United States: Institutional Review Board |
Pancreatic Cancer |
Capecitabine Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Gemcitabine Pancrelipase Endocrine Gland Neoplasms Carcinoma |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |