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

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

This study is testing if combining proton radiation with a chemotherapy pill can help pancreatic cancer patients who can't have surgery become eligible for surgery later on.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Proton Collaborative Group (Research network)
• Drugs / interventions: radiation, chemotherapy
• Locations: 4 sites (Jacksonville, Florida and 3 other locations)
• Trial ID: NCT02598349 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals with biopsy-proven unresectable or borderline resectable pancreatic adenocarcinoma who are not eligible for surgery.

Not a fit: Patients with evidence of distant metastasis or those who have previously undergone surgical resection will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve surgical resection rates and extend survival for patients with pancreatic cancer who are not surgical candidates.

How similar studies have performed: Other studies have shown promising results with proton therapy for various cancers, suggesting potential success for this approach in pancreatic cancer.

Eligibility criteria

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 this trial is running

Jacksonville, Florida and 3 other locations

• University of Florida Proton Therapy Institute — Jacksonville, Florida, United States (Active_not_recruiting)
• Northwestern Medicine Chicago Proton Center — Warrenville, Illinois, United States (Recruiting)
• McLaren Proton Therapy Center — Flint, Michigan, United States (Recruiting)
• Inova Schar Cancer Institute — Fairfax, Virginia, United States (Recruiting)

Study contacts

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

Conditions Pancreatic Cancer; Unresectable; Borderline resectable