Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas (PC04) (PC04)
|Pancreatic Cancer||Radiation: Proton Radiation Drug: Capecitabine Procedure: Surgical resection Behavioral: FACT-Hep questionnaire||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
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|
- 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%.
- 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.
|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)|
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 RadiationDrug: Capecitabine
Concomitant oral chemotherapy, capecitabine 1000mg by mouth twice daily, 5 days a week (M-F) on radiation days only.
Other Name: XelodaProcedure: 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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02598349
|Contact: Intake Coordinator||877-686-6009|
|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|
|Principal Investigator:||Romaine C. Nichols, MD||UF Health Proton Therapy Institute|