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

  • End date
    Oct 23, 2040
  • participants needed
  • sponsor
    Proton Collaborative Group
Updated on 23 January 2021
platelet count
pancreatic adenocarcinoma
cancer chemotherapy
biliary obstruction


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).


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.

Condition Pancreatic Cancer, Pancreatic disorder, Neoplasm of unspecified nature of digestive system, Pancreatic Disorders, Islet Ce417ll Cancer, Digestive System Neoplasms, cancer of the pancreas, pancreatic cancers, cancer, pancreatic
Treatment Capecitabine, Surgical Resection, Proton Radiation, FACT-Hep questionnaire
Clinical Study IdentifierNCT02598349
SponsorProton Collaborative Group
Last Modified on23 January 2021


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Pancreatic Cancer?
Do you have any of these conditions: Pancreatic Disorders or pancreatic cancers or Digestive System Neoplasms or Neoplasm of unspecified nature of digestive system or Pancreatic disorder ...?
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Phone Email

Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note