Phase ǀ Study on Pancreatic Cancer Treated by CyberKnife
Pancreatic Tumor
About this trial
This is an interventional treatment trial for Pancreatic Tumor focused on measuring Stereotactic Body Radiotherapy (SBRT), CyberKnife, Dose Escalation
Eligibility Criteria
Inclusion Criteria:
- Unresectable pancreatic adenocarcinoma or unsuitable/unwilling for resection which is proved by biopsy.
- A life expectancy of >3months
- Eastern Cooperative Oncology Group (ECOG) status ≤2
- Tumor size < 5 cm
- Tumor location: Head of pancreas
- Patients must be able to undergo contrast enhanced CT for planning
- Absolute neutrophil count (ANC) ≥ 1.5 ×109 cells/L
- Leukocyte count≥ 3.5 ×109cells/L
- Platelets ≥ 70×109cells/L
- Hemoglobin ≥ 8.0 g/dl
- Albumin > 2.5 g/dL
- Total bilirubin < 3 mg/dL
- Creatinine < 2.0 mg/dL
- INR < 2 (0.9-1.1)
- Aspartate transaminase (AST) <2.5 × Upper Limit of Normal (ULN )(0-64U/L)
- Alanine aminotransferase (ALT) <2.5 × ULN(0-64U/L)
- Both men and women and members of all races and ethnic groups are eligible for this study
- Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document
- Tumor markers and lab test should be done less than 1 week before recruitment
Exclusion Criteria:
- Prior surgery, chemotherapy or radiation for the pancreatic tumor
- Prior radiotherapy to the upper abdomen, evidence of metastatic disease such as nodal or distant metastases by abdomen CT and chest CT or FDG PET-CT
- Contraindication to receiving radiotherapy
- Distance between gross tumor volume (GTV) (lesion) and luminal structures (including liver, stomach, duodenum, small or large bowel) is<5 mm
- Women who are pregnant
- Participation in another clinical treatment trial while on study
- Patients in whom fiducial implantation was not possible
Sites / Locations
- Huojun Zhang
- HuojunZhang
Arms of the Study
Arm 1
Experimental
Maximal tolerated dose with CyberKnife
SBRT will be delivered in 5 fractions within 1 to 2 weeks by the following schedule: Doses of 7 Gy, 7.5 Gy, 8 Gy, 8.5 Gy, 9 Gy, 9.5 Gy x 5 with BED10 in correspondence to 59.5 Gy, 65.6 Gy, 72 Gy, 78.6 Gy, 85.5 Gy, 92.6 Gy respectively while meeting with normal tissue constraints. A minimum of three patients will be included for each dosage level. And an interval is four weeks between each dose level. In case patient presents III/IV GI toxicity, three additional patients will be included at the same dose level. The Maximal Tolerated Dose will be defined as the dose for which at least 2 patients in 3, or at least 3 patients in 9, will present with a limiting toxicity.