Proton radiation treatment for pancreatic cancer patients who can't have surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of proton radiation combined with oral chemotherapy (capecitabine) for patients with unresectable, borderline resectable, or medically inoperable pancreatic cancer. Participants will receive proton radiation over a six-week period, with capecitabine administered only on radiation days. The goal is to determine if this combined treatment increases the number of patients who can undergo surgical resection compared to historical data. If surgery is deemed possible, it will be performed at least eight weeks after the completion of radiation and chemotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Where it's running

• Proton Center of Arkansas
  Little Rock, Arkansas, United States Recruiting
• Northwestern Medicine Chicago Proton Center
  Warrenville, Illinois, United States Recruiting
• McLaren Proton Therapy Center
  Flint, Michigan, United States Recruiting
• University of Florida Proton Therapy Institute
  Jacksonville, Florida, United States Active not recruiting

Study contacts

• Principal investigator: Romaine C. Nichols, MD — UF Health Proton Therapy Institute

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.