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Proton Therapy for Resectable Carcinoma of the Pancreas (PC02)
This study is currently recruiting participants.
Verified by University of Florida, October 2008
Sponsored by: University of Florida
Information provided by: University of Florida
ClinicalTrials.gov Identifier: NCT00763516
  Purpose
  1. Chemotherapy and Radiation Combination

    • Capecitabine (Xeloda®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.
    • Proton radiation to the tumor to a dose of 50.4 CGE in 28 treatments over 6 weeks.

    Followed by:

  2. Surgery - total resection of primary tumor and regional lymph nodes

    Followed by:

  3. Additional Chemotherapy

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

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Capecitabine Pancrelipase Ultrase
U.S. FDA Resources
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

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Collect and analyze morbidity outcomes of protocol treatment [ Time Frame: After RT; then every 3 months during first two years; every 6 months during years 3-5; then annually ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Collect and analyze tumor control outcomes [ Time Frame: After RT; then every 3 months during first two years; every 6 months during years 3-5; then annually ] [ Designated as safety issue: No ]

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
  1. Chemotherapy and Radiation Combination

    1. Capecitabine (Xeloda®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.
    2. Proton radiation to the tumor to a dose of 50.4 CGE in 28 treatments over 6 weeks.

    Followed by:

  2. Surgery - total resection of primary tumor and regional lymph nodes

    Followed by:

  3. Additional Chemotherapy

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
  1. Chemotherapy and Radiation Combination

    1. Capecitabine (Xeloda®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.
    2. Proton radiation to the tumor to a dose of 50.4 CGE in 28 treatments over 6 weeks.

    Followed by:

  2. Surgery - total resection of primary tumor and regional lymph nodes

    Followed by:

  3. Additional Chemotherapy

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


Detailed Description:

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*

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed adenocarcinoma of the pancreas.
  • Patients must have marginally resectable disease based on radiological and laparoscopic assessment; disease shows abutment (loss of fat plane and ≤ 180 degree involvement of the circumference of the vessel) of the celiac axis, hepatic artery, superior mesenteric vein [SMV]or artery [SMV] or disease that encases a short segment (normal vessel above and below amenable to reconstruction) of the hepatic artery or portal vein [PV] without extension to the celiac axis or judged to be marginally resectable by a surgeon for other reasons.
  • Patients with biliary obstruction must have adequate drainage (biliary stent ≥ 9F or biliary bypass to maintain function until surgical resection) prior to starting chemoradiation.
  • All patients must have radiographically assessable disease that is encompassable within a reasonable irradiation volume.
  • Zubrod performance status 0-2 within 6 weeks prior to treatment.
  • All patients will undergo pretreatment evaluation of tumor extent and tumor measurement per RECIST. Patients must complete all required testing as listed in section 4.
  • Required pretreatment laboratory parameters:

    • absolute granulocyte/neutrophil count (AGC/ANC) ≥ 1.8 thou/mm3
    • platelet count ≥ 100,000/mm3
    • bilirubin < 2 mg/dl
    • ALT/SGPT < 3x upper limit of normal
    • creatinine < 3 mg/dl
    • calculated creatinine clearance > 30 mL/min
  • Signed study specific, IRB stamped informed consent.
  • Age ≥ 18 years at time of consent.
  • The patient's nutritional and general physical condition must be considered compatible with the proposed treatment.
  • cT1-3N0-1M0; stage 1a-2b.

Exclusion Criteria:

  • Evidence of distant metastasis; evidence of metastatic disease in the major viscera (organs), peritoneal seeding and/or ascites.
  • Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment.
  • Prior surgical resection.
  • Other malignancy (except non-melanoma skin cancer) that has not been disease-free for at least 5 years.
  • Active, untreated infection.
  • Serious medical, psychiatric and/or addictive illness that would preclude the consent process, treatment and/or follow-up compliance.
  • Pregnant and/or breast-feeding women, or patients of child-producing potential not willing to use contraception while on treatment and for at least 3 months thereafter.
  • Chemotherapy within 6 months prior to study.
  • Gastroduodenal obstruction.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763516

Contacts
Contact: Amanda D Prince, RN (904) 588-1298 aprince@floridaproton.org
Contact: Cindy L Carroll (904) 588-1288 ccarroll@floridaproton.org

Locations
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    
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Felicia E Snead, MD University of Florida Proton Therapy Institute
  More Information

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

Keywords provided by University of Florida:
Pancreatic Cancer

Study placed in the following topic categories:
Capecitabine
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Pancrelipase
Endocrine Gland Neoplasms
Carcinoma

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009