Status:
COMPLETED
Radiation Therapy and Capecitabine/Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma
Lead Sponsor:
University of Utah
Conditions:
Cancer
Pancreas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The study is a prospective phase I trial of radiation therapy concurrent with capecitabine and oxaliplatin chemotherapy in the treatment of locally advanced pancreas adenocarcinoma. Eligibility criter...
Detailed Description
Patients will undergo radiation therapy (28 treatments of 1.8 Gy for a total of 50.4 Gy) concurrent with capecitabine and oxaliplatin chemotherapy. The primary objective of the study is to determine t...
Eligibility Criteria
Inclusion
- Patient Selection Criteria
- Pathologically confirmed adenocarcinoma of the pancreas.
- No distant metastases (no metastases beyond regional lymph nodes).
- Deemed surgically unresectable by a surgical oncologist due to hepatic artery, celiac axis, superior mesenteric artery, superior mesenteric vein, portal vein, aorta, inferior vena cava, and/or rib/vertebral body involvement as defined by CT/MRI scan and/or endoscopic ultrasound (EUS).
- No malignancy (within the past two years) except for non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder.
- No previous chemotherapy for pancreatic cancer.
- No prior irradiation to the planned field.
- Zubrod performance status 0-1.
- Granulocytes \> 1,800, platelets \> 100,000/ul, bilirubin \< 2.0 mg/dL, ALT \< 3x upper limits of normal, creatinine \< 3.0 mg/dL.
- No significant infection or other coexistent medical condition.
- No pregnant or lactating women.
- Age \> 18 years old.
- Signed study-specific consent form prior to registration.
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00707278
Start Date
September 1 2005
End Date
August 1 2011
Last Update
October 31 2014
Active Locations (1)
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1
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112