Pancreatic Cancer
Conditions
Keywords
Unresectable, Borderline resectable
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).
Detailed description
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.
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.
Sponsors
University of Florida Health
Proton Collaborative Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival at 12 months after radiation therapy | 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
| Measure | Time frame | Description |
|---|---|---|
| Surgical resection rate. | 3 months following the completion of radiation therapy. | Increase share of marginally resectable and unresectable patients being converted to resectable. |
Countries
United States
Outcome results
None listed