RecruitingPhase 2NCT02598349

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

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

Sponsor

Proton Collaborative Group

Enrollment

60 participants

Start Date

Apr 1, 2016

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is using proton radiation therapy — a precise form of radiation that delivers less damage to surrounding healthy tissue — to treat patients with pancreatic cancer that cannot be removed by surgery, either because it is too advanced, borderline operable, or the patient is not healthy enough for surgery. **You may be eligible if...** - You have biopsy-confirmed pancreatic adenocarcinoma (the most common type of pancreatic cancer) - Your cancer is unresectable (cannot be surgically removed), borderline resectable, or you are medically unfit for surgery or have declined surgery - If you have a bile duct blockage, a drainage tube is already in place - Your blood counts, liver function, and kidney function meet the minimum required levels - You are willing to use contraception during and for at least 12 months after treatment **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body (metastatic) - You have previously had abdominal radiation - You have previously had pancreatic surgery - You have had another invasive cancer (except non-melanoma skin cancer or low-risk prostate cancer) within the past 5 years - You have an active, untreated infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONProton 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.

DRUGCapecitabine

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

PROCEDURESurgical resection

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