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

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ClinicalTrials.gov Identifier: NCT02598349
Recruitment Status : Recruiting
First Posted : November 5, 2015
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
University of Florida Health
Information provided by (Responsible Party):
Proton Collaborative Group

Tracking Information
First Submitted Date  ICMJE November 4, 2015
First Posted Date  ICMJE November 5, 2015
Last Update Posted Date July 12, 2019
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date October 2039   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
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%.
Original Primary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
The percentage of participants that are able to undergo surgical resection compared to historical benchmarks. [ Time Frame: Approximately 12 months post radiation therapy ]
Improve 12 month survival from 50% to 75%
Change History Complete list of historical versions of study NCT02598349 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2015)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas
Official Title  ICMJE 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
Brief Summary 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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.

Interventions:
  • Radiation: Proton Radiation
  • Drug: Capecitabine
  • Procedure: Surgical resection
  • Behavioral: FACT-Hep questionnaire
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2015)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2040
Estimated Primary Completion Date October 2039   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tish Adams, MS, CCRC, CP 913-788-6429 tadams@pcgresearch.org
Contact: Matthew Morocco, BS 630-836-8670 mmorocco@pcgresearch.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02598349
Other Study ID Numbers  ICMJE PAN009-18
UFPTI-1510-PC04 ( Other Identifier: University of Florida Health Proton Therapy Institute )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Proton Collaborative Group
Study Sponsor  ICMJE Proton Collaborative Group
Collaborators  ICMJE University of Florida Health
Investigators  ICMJE
Principal Investigator: Romaine C. Nichols, MD UF Health Proton Therapy Institute
PRS Account Proton Collaborative Group
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP