None listed
Conditions
Interventions
Drug, Radiation : 34 patients will be accrued. Stereotactic body radiotherapy (6 Gy x 5, daily) is delivered using a TomoTherapy Hi-Art (TomoTherapy, Madison, WI, USA) and 5-fluorouracil (400 mg/m2/we
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the pancreas. 2. Unresectable disease. Tumors were considered to be unresectable if they demonstrated any of the following finding: (a) superior mesenteric artery or celiac encasement greater than 180 degrees, (b) unreconstructible superior mesenteric vein/portal occlusion or (c) aortic invasion; 3. An age = 18 years. 4. An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. 5. Adequate bone marrow functional reserve (leukocytes >3,000/µL, an absolute neutrophil count >1,500/µL and a platelet count >100,000/µL). 6. Adequate hepatic and renal functional reserve (total bilirubin <1.5 times the institutional limits, aspartate aminotransferase/alanine aminotransferase <2.5 times the institutional limits and creatinine within the institutional limits). 7. Signed informed consent must be obtained prior to any of the study's specific procedures.
Exclusion criteria
Exclusion criteria: 1. Distant metastases or resectable disease. 2. Gastric/duodenal wall invasion or regional lymph node metastases. 3. Patients who have had prior radiotherapy to the upper abdomen. 4. Pregnant and breastfeeding women or women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy. 5. Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with the study requirements. 6. Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy without evidence of disease for > 5 years will be allowed to enter the trial. 7. Patients who had uncontrolled gastric or duodenal ulcer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| one-year progression-free survival;late (more than 3 months after completion of stereotactic body radiotherapy) grade 2 or worse gastrointestinal toxicities | — |
Secondary
| Measure | Time frame |
|---|---|
| one-year local control rate;one-year overall survival rate;acute (within 3 months after completion of SBRT) grade 2 or worse gastrointestinal toxicities;the efficacy of positron emission tomography-computed tomography (PET-CT) for assessing the response and local progression after treatment | — |
Countries
Korea, Republic of
Contacts
Public ContactJong Hoon Lee
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed