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NCT Number: NCT02598349

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

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).

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Florida Proton Therapy Institute, Jacksonville, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Proton Radiation

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.

Other names: Proton Beam Radiation

Capecitabine

Drug

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

Other names: Xeloda

Surgical resection

Procedure

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

Primary outcomes

  1. Overall survival at 12 months after radiation therapy

    Time frame: Approximately 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%.

Secondary outcomes

  1. Surgical resection rate.

    Time frame: 3 months following the completion of radiation therapy.

    Increase share of marginally resectable and unresectable patients being converted to resectable.

Sponsors and collaborators

Lead sponsor

Proton Collaborative Group

Network

Collaborators

  • University of Florida Health

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2039
Study completion
2040
First posted
Nov 5, 2015
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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