Proton Radiation for Resectable Carcinoma of the Pancreas

NCT00763516 | Completed DMC

• 1 other identifier: UFPTI 0704-PC02
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out what effects, good and/or bad, proton radiation combined with chemotherapy and surgery has on you and your pancreatic cancer. This study will look at the side effects from the treatment and the quality of your life in relation to pain. It will also look at how the tumor responds to the combination of treatment with radiation, chemotherapy and surgery.

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; Proton radiation; Chemotherapy; Xeloda; Gemzar; Resectable; Surgery

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of grade 3+ bowel perforation, grade 3+ bleeding and grade 4+ nonhematologic acute adverse events (occuring within 90 days of treatment start)

  1 year following the completion of radiation therapy

Secondary Outcomes (1)

• Collect and analyze tumor control outcomes

  1 year following the completion of radiation therapy

Study Arms (1)

Proton radiation and chemotherapy

EXPERIMENTAL

Proton radiation Capecitabine chemotherapy on radiation days Surgery Gemcitabine chemotherapy

Radiation: Proton radiation and chemotherapy

Interventions

Proton radiation and chemotherapy RADIATION

Neoadjuvant Chemotherapy Capecitabine (Xeloda®) 1,000 mg by mouth twice a day 5 days/week (M-F) on radiation days only Proton radiation 50.4 cobalt gray equivalent(CGE) in 28 fractions over 6 weeks Surgery: Gross total resection of primary tumor and regional lymph nodes done 6 weeks after completion of radiation Adjuvant Chemotherapy starting 2-8 weeks after surgery Suggested Regimen: Gemcitabine (Gemzar®) 1,000 mg/m2 IV total of 18 doses

Also known as: Xeloda, Gemzar

Proton radiation and chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed adenocarcinoma of the pancreas.
• Patients must have marginally resectable disease.
• Patients with biliary obstruction must have adequate drainage prior to starting chemoradiation.

You may not qualify if:

• Evidence of distant metastasis including peritoneal seeding and/or ascites.
• Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment.
• Prior surgical resection.
• Gastroduodenal obstruction

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Related Publications (30)

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  BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Drug Therapy; Capecitabine; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Romaine C Nichols, MD

  University of Florida Proton Therapy Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 1, 2008
• Study Start: February 1, 2009
• Primary Completion: August 17, 2017
• Study Completion: August 17, 2017
• Last Updated: September 6, 2017

Record last verified: 2017-09

Locations

US (1)