Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas (PC04) (PC04)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02598349|
Recruitment Status : Recruiting
First Posted : November 5, 2015
Last Update Posted : February 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Radiation: Proton Radiation Drug: Capecitabine Procedure: Surgical resection Behavioral: FACT-Hep questionnaire||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||October 2039|
|Estimated Study Completion Date :||October 2040|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|