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Proton Radiation for Pancreatic Cancer

This study is testing a combination of treatments for pancreatic cancer that cannot be removed by surgery, is borderline resectable (meaning surgery might be possible after treatment), or if you cannot have surgery for medical reasons. You would receive Proton Radiation (a type of radiation therapy) along with an oral chemotherapy drug called Capecitabine. For some participants, if imaging shows the tumor can be removed after these treatments, surgery might be an option 8 to 16 weeks later. The main goal is to see how long people live after radiation therapy, specifically at 12 months. This study is currently recruiting about 60 participants.

Study design
This is an interventional study involving approximately 60 participants. It is testing a specific treatment combination.
What's involved
You would receive Proton Radiation over 6 weeks, with oral Capecitabine taken on radiation days. If surgery becomes an option, it would be performed 8 to 16 weeks after radiation and chemotherapy.
Compensation
Not stated in the trial record.
Follow-up
Your overall survival will be measured at approximately 12 months after radiation therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02598349

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Proton Collaborative Group
~60 participants
Updated 2025-09-09 on ClinicalTrials.gov
What's tested:Proton RadiationCapecitabineSurgical resection

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival at 12 months after radiation therapy
Measured over Approximately 12 months after radiation therapy.

Conditions

Pancreatic Cancer

Explore related trials

Pancreatic Carcinoma

Where it's being run

4 sites across 4 states
Florida1
Illinois1
Michigan1
Virginia1

Study leadership

  • Romaine C. Nichols, MD · PRINCIPAL_INVESTIGATOR · UF Health Proton Therapy Institute

Who to contact

Don Smith, MS, CCRC
[email protected]
630-933-7820
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Overall survival at 12 months after radiation therapyApproximately 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%.