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Recruiting

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

NCT02598349 · Proton Collaborative Group
In plain English

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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
About this study
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.
Eligibility 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.
Study design
Enrollment target: 60 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2016-04
Estimated completion: 2040-10
Last updated: 2025-09-09
Interventions
Radiation: Proton RadiationDrug: CapecitabineProcedure: Surgical resection
Primary outcomes
  • Overall survival at 12 months after radiation therapy (Approximately 12 months after radiation therapy.)
Sponsor
Proton Collaborative Group · network
With: University of Florida Health
Contacts & investigators
InvestigatorRomaine C. Nichols, MD · principal_investigator, UF Health Proton Therapy Institute
All locations (4)
University of Florida Proton Therapy InstituteActive Not Recruiting
Jacksonville, Florida, United States
Northwestern Medicine Chicago Proton CenterRecruiting
Warrenville, Illinois, United States
McLaren Proton Therapy CenterRecruiting
Flint, Michigan, United States
Inova Schar Cancer InstituteRecruiting
Fairfax, Virginia, United States
Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas · TrialPath