Recruiting
Phase 2

Proton Radiation

Sponsor:

Proton Collaborative Group

Code:

NCT02598349

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Proton Radiation

Capecitabine

Surgical resection

Study Details

Brief summary:

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).

Conditions

Pancreatic Cancer

Study ID

NCT02598349

Start date

Apr, 2016

Status verified date

Sep, 2025

Completion date

Oct, 2040

Anticipated

Primary completion date

Oct, 2039

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Capecitabine

Concomitant oral chemotherapy, capecitabine 1000mg by mouth twice daily, 5 days a week (M-F) on radiation days only.

Surgical resection

Surgery between 8 and 16 weeks of radiotherapy completion if radiographic studies suggest operability.

Primary outcome measure

  • Overall survival at 12 months after radiation therapy [ Time Frame: Approximately 12 months after radiation therapy. ]

Central Contacts and Locations

Locations

Northwestern Medicine Chicago Proton Center

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Don Smith, MS, CCRC

630-933-7820donald.smith3@nm.org

Principal Investigator:

Nasiruddin Mohammed, MD

McLaren Proton Therapy Center

Recruiting

Flint, Michigan, United States, 48532

Contacts

Taylor Brewer

313-576-8526brewert@karmanos.org

Principal Investigator:

Brian Yeh, MD

Inova Schar Cancer Institute

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Sangeetha Moturi

571-472-0343sangeetha.moturi@inova.org

Principal Investigator:

Michael Eblan, MD

More Information

Sponsor

Proton Collaborative Group

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • Unresectable
  • Borderline resectable

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Proton Collaborative Group on 2025-09-09.