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Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas (PC04) (PC04)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT02598349
First received: November 4, 2015
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical candidates is poor. Patients characterized as having "borderline resectable" disease treated with preoperative chemo-radiotherapy fair somewhat better - although many of these patients are not converted to resectability. It may be argued that intensification of local and regional therapy might 1.) Increase the share of patients able to undergo curative surgery and 2.) Improve the local disease control interval and extend survival for patients who remain unresectable. Therefore, the purpose of this research study is to determine if an increase in the number of surgical resection pancreatic adenocarcinoma is higher than historical data by using a combined treatment of proton radiation with capecitabine (oral chemotherapy).

Condition Intervention Phase
Pancreatic Cancer
Radiation: Proton Radiation
Drug: Capecitabine
Procedure: Surgical resection
Behavioral: FACT-Hep questionnaire
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Trial of Escalated Dose Proton Radiotherapy With Elective Nodal Irradiation and Concomitant Chemotherapy for Patients With Unresectable, Borderline Resectable or Medically Inoperable Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Overall survival at 12 months after radiation therapy [ Time Frame: Approximately 12 months after radiation therapy. ]
    The trial is designed to allow detection of an improvement in the 12 month overall survival rate to 75% compared to the expected historical rate of 50%.


Secondary Outcome Measures:
  • Surgical resection rate. [ Time Frame: 3 months following the completion of radiation therapy. ]
    Increase share of marginally resectable and unresectable patients being converted to resectable.


Estimated Enrollment: 60
Study Start Date: April 2016
Estimated Study Completion Date: October 2040
Estimated Primary Completion Date: October 2039 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Radiation with capecitabine

The following will be performed in this group: Proton Radiation Therapy with concomitant oral chemotherapy, capecitabine taken on radiation treatment days for 6 weeks. A surgical resection will be performed between 8 and 16 weeks if radiographic studies suggest operability.

Additionally, a Functional Assessment of Cancer Therapy (FACT-Hep) questionnaire is to be filled out by participants at baseline, at week 4 and week 6, then 1 month after completion of treatment, then every 3 months for 1 year, and then every 6 months for 3 years. The FACT-Hep questionnaire is specific to those with gastrointestinal cancers focusing on hepatobiliary and pancreatic cancer.

Radiation: Proton Radiation
Proton Radiation 40.50 Gy relative biological effectiveness (RBE) in 18 fractions to gross disease and elective nodal volume followed by a 22.50 Gy (RBE) in 10 fraction boost to gross disease. Total dose 63 Gy (RBE) in 28 fractions over 6 weeks.
Other Name: Proton Beam Radiation
Drug: Capecitabine
Concomitant oral chemotherapy, capecitabine 1000mg by mouth twice daily, 5 days a week (M-F) on radiation days only.
Other Name: Xeloda
Procedure: Surgical resection
Surgery between 8 and 16 weeks of radiotherapy completion if radiographic studies suggest operability.
Behavioral: FACT-Hep questionnaire
The FACT-Hep questionnaire is specific to those with gastrointestinal cancers focusing on hepatobiliary and pancreatic cancer.
Other Name: Functional Assessment of Cancer Therapy (FACT) questionnaire

Detailed Description:

Participants as part of this research study will receive Proton radiation over 6 weeks with oral chemotherapy (capecitabine) only taken on radiation days.

In addition, If surgery is an option, then surgical resection will be performed at least 8 weeks after treatment with radiation and chemotherapy.

Quality of Life questionnaires are a part of this study.The Fact-Hep questionnaires will be filled out by the participant at strategic time points in the treatment course.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven unresectable adenocarcinoma of the pancreas.
  • Have either unresectable, borderline resectable or medically inoperable carcinoma of the pancreas, or refusing surgery.
  • A biliary obstruction is able to participate as long as a drainage tube is in place prior to starting treatment with Proton radiation,
  • Participants of child-producing potential must be willing to use contraception while on treatment and for at least 12 months thereafter.
  • Required pretreatment laboratory parameters:

    • Absolute granulocyte 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

Exclusion Criteria:

  • Evidence of distant metastasis.
  • Prior surgical resection.
  • Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the participant has been disease free for 5 years prior to registration.
  • Active or untreated infection,
  • Pregnant or breastfeeding women or subjects of child producing potential not willing to use medically acceptable contraception while on treatment and for at least 12 months thereafter.
  • Previous Radiation to the abdomen.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02598349

Contacts
Contact: Deborah Martinez, RN, CCRP 904-588-1303 dmartinez@floridaproton.org

Locations
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator    877-686-6009      
Principal Investigator: R. Charles Nichols, MD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Romaine C. Nichols, MD UF Health Proton Therapy Institute
  More Information

Additional Information:
Publications:
R. C. Nichols, C. G. Morris, D. Bose, S. J. Hughes, J. A. Stauffer, S. A. Celinski, R. C. Martin II, E. A. Johnson, R. A. Zaiden, M. S. Rutenberg ;O51: Feasibility of pancreatectomy after high dose proton therapy for unresectable pancreatic cancer. (2014) Proceedings to the 1 Annual Meeting for the Particle Therapy Cooperative Group - North America (PTCOG-NA), 27-29 October 2014. International Journal of Particle Therapy: Winter 2014, Vol. 1, No. 3, pp. 759-824.

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02598349     History of Changes
Other Study ID Numbers: UFPTI-1510-PC04
Study First Received: November 4, 2015
Last Updated: March 21, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Unresectable
Borderline resectable

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on March 30, 2017