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
Proton Collaborative Group
60 participants
Apr 1, 2016
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- 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 Criteria6
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Concomitant oral chemotherapy, capecitabine 1000mg by mouth twice daily, 5 days a week (M-F) on radiation days only.
Surgery between 8 and 16 weeks of radiotherapy completion if radiographic studies suggest operability.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02598349