RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2016-04
Study Completion:2040-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02598349

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Biopsy proven unresectable adenocarcinoma of the pancreas.
  2. * Have either unresectable, borderline resectable or medically inoperable carcinoma of the pancreas, or refusing surgery.
  3. * A biliary obstruction is able to participate as long as a drainage tube is in place prior to starting treatment with Proton radiation,
  4. * Participants of child-producing potential must be willing to use contraception while on treatment and for at least 12 months thereafter.
  5. * Required pretreatment laboratory parameters:
  6. * Absolute granulocyte count (AGC/ANC) ≥ 1.8 thou/mm3
  7. * Platelet count ≥ 100,000/mm3
  8. * Bilirubin \< 2 mg/dl
  9. * ALT/SGPT \< 3x upper limit of normal
  10. * Creatinine \< 3 mg/dl
  1. * Evidence of distant metastasis.
  2. * Prior surgical resection.
  3. * 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.
  4. * Active or untreated infection,
  5. * 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.
  6. * Previous Radiation to the abdomen.

Contacts and Locations

Principal Investigator

Romaine C. Nichols, MD
PRINCIPAL_INVESTIGATOR
UF Health Proton Therapy Institute

Study Locations (Sites)

University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206
United States
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, 60555
United States
McLaren Proton Therapy Center
Flint, Michigan, 48532
United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Proton Collaborative Group

  • Romaine C. Nichols, MD, PRINCIPAL_INVESTIGATOR, UF Health Proton Therapy Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-04
Study Completion Date2040-10

Study Record Updates

Study Start Date2016-04
Study Completion Date2040-10

Terms related to this study

Keywords Provided by Researchers

  • Unresectable
  • Borderline resectable

Additional Relevant MeSH Terms

  • Pancreatic Cancer