Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer
Not Applicable
Completed
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT02454140
- Lead Sponsor
- University of California, San Diego
- Brief Summary
This study is to determine the maximum tolerated dose (MTD) of five fraction stereotactic radiotherapy (SBRT) in pancreatic cancer.
- Detailed Description
This trial is designed to find the maximum tolerated dose of radiation under a fixed 5-fraction SBRT regimen escalating the dose from 40 Gy in 5 fractions, to 60 Gy in 5 fractions, at 5 Gy intervals.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Diagnosis: Histologically-proven invasive adenocarcinoma of the pancreas.
- Disease Status: Medically unresectable (any stage), or locally advanced (stage III).
- Tumor Location: Primary tumor may be located anywhere in the pancreas.
- Treatment eligibility: The patient must be able to have fiducial markers implanted into the pancreatic tumor, and receive radiation regimen as specified in the protocol.
- Performance Level: Karnofsky Performance Status ≥ 60
- Adequate Renal Function Defined As: Serum creatinine ≤ 1.5 x upper limit of normal
- Informed Consent: All subjects must sign a written informed consent.
Exclusion Criteria
- Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events. (Note: Serum Pregnancy tests must be obtained in women of child bearing potential). Sexually active females may not participate unless they have agreed to use an effective contraceptive method (such as abstinence, diaphragm, condom, or intrauterine device) to prevent pregnancy for the duration of the study.
- Life expectancy < 6 months
- The patient cannot have had prior radiation therapy to the thorax or upper abdomen.
- Incarcerated individuals
- Subjects unable to give informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose From date of randomization to observed dose limiting toxicity (DLT) in 20% of patients assessed up to 3 years The purpose of this study is to determine the maximum tolerated dose of five fraction stereotactic radiotherapy (SBRT) in pancreatic cancer.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UCSD Moores Cancer Center
🇺🇸La Jolla, California, United States
UCSD Moores Cancer Center🇺🇸La Jolla, California, United States