Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas
|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 : November 1, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Radiation: Proton Radiation Drug: Capecitabine Procedure: Surgical resection||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.
|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.
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
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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
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: Matthew Moroccofirstname.lastname@example.org|
|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|
|United States, Illinois|
|Northwestern Medicine Chicago Proton Center||Recruiting|
|Warrenville, Illinois, United States, 60555|
|Contact: Don Smith, MS, CCRC 630-933-7820 email@example.com|
|Principal Investigator: Nasiruddin Mohammed, MD|
|United States, Virginia|
|Inova Schar Cancer Institute||Recruiting|
|Fairfax, Virginia, United States, 22031|
|Contact: Sangeetha Moturi 571-472-0343 firstname.lastname@example.org|
|Principal Investigator: Michael Eblan, MD|
|Principal Investigator:||Romaine C. Nichols, MD||UF Health Proton Therapy Institute|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Proton Collaborative Group|
|Other Study ID Numbers:||
UFPTI-1510-PC04 ( Other Identifier: University of Florida Health Proton Therapy Institute )
|First Posted:||November 5, 2015 Key Record Dates|
|Last Update Posted:||November 1, 2021|
|Last Verified:||October 2021|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Molecular Mechanisms of Pharmacological Action