Status:
COMPLETED
Study of Low-Dose Fractionated Radiotherapy in Patients With Locally Advanced Metastatic Pancreatic Cancer
Lead Sponsor:
Fox Chase Cancer Center
Conditions:
Pancreatic Carcinoma Non-resectable
Metastatic Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
People with pancreatic cancer usually have a large amount of the cancer in the area of the pancreas and around it when they are diagnosed with it. Or their cancer has spread (metastasized)outside that...
Detailed Description
Pancreatic cancer is nearly universally fatal, with approximately 38,000 new cases and 34,000 deaths expected in 2008.1 The majority of patients present with disease that is not amenable to curative r...
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of adenocarcinoma of the pancreas that is not amenable to curative surgical resection. Patients with locally advanced unresectable disease and those patients with metastatic disease that can be encompassed in the radiation fields for this study (as assessed by treating radiation oncologist) are eligible.
- Patients may not have received any prior chemotherapy for locally advanced or metastatic pancreatic cancer. Prior adjuvant chemotherapy completed \>1 year previously is allowed.
- Patients must be able to provide informed consent and HIPAA consent.
- Patients must be ≥18 years of age
- Adequate hematologic and organ function:
- ANC ≥ 1,000/μL, platelets ≥ 100,000/μL, hemoglobin ≥ 9.0/dL
- Bilirubin: ≤1.5X ULN
- ALT/AST \< 3.0 X upper limit of normal
- Serum Creatinine: WNL
- Albumin \> 2.5 g/dL
- Measurable and non-measurable disease are permitted
- ECOG performance status 0-1
- Patients must be able to swallow oral medications
- Patients must be able to comply with study and follow up procedures
Exclusion
- No prior radiation therapy to the abdomen.
- Patients must not have any other active illness (e.g. active/uncontrolled infection, uncontrolled cardiac disease, etc.) that would preclude safe therapy in the judgment of the treating physicians. Patients may be enrolled while still on antibiotics as long as clinical signs of active infection are absent.
- Patients with concurrent active malignancy requiring therapy are not eligible. Patients with a history of malignancy within any timeframe not requiring ongoing therapy are eligible.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00761345
Start Date
September 1 2008
End Date
February 1 2015
Last Update
March 7 2017
Active Locations (3)
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1
Karmanos Cancer Institue
Detroit, Michigan, United States, 48201
2
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
3
Reading Medical Center
West Reading, Pennsylvania, United States, 19611