Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas (PC04)
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/18/2019 |
| Start Date: | April 2016 |
| End Date: | October 2040 |
| Contact: | Intake Coordinator |
| Phone: | 877-686-6009 |
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
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).
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).
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.
Quality of Life questionnaires are a part of this study.The Fact-Hep questionnaires will be
filled out by the participant at strategic time points in the treatment course.
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.
Quality of Life questionnaires are a part of this study.The Fact-Hep questionnaires will be
filled out by the participant at strategic time points in the treatment course.
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.
We found this trial at
1
site
2015 Jefferson St
Jacksonville, Florida 32206
Jacksonville, Florida 32206
(904) 588-1800
Principal Investigator: R. Charles Nichols, MD
Phone: 877-686-6009
University of Florida Proton Therapy Institute When the University of Florida Proton Therapy Institute opened...
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