Clinical trial NCT02454140: Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer
Official title: Phase I Trial of Adaptive Stereotactic Body Radiotherapy (SBRT) Dose Escalation in Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: From date of randomization to observed dose limiting toxicity (DLT) in 20% of patients assessed up to 3 years
Secondary outcomes:
measure: Local Tumor Progression
timeFrame: From date of randomization until local disease progression defined as a ≥20% increase in size on CT compared with CT prior to SBRT assessed over 3 years
measure: Distant Metastatic Progression Rate
timeFrame: From date of randomization until the appearance of new lesions or a ≥20% increase in size on CT of the previously noted metastatic lesions assessed over 3 years
measure: Overall Survival
timeFrame: From date of diagnosis and SBRT to date of death assessed over 3 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
Study officials:
affiliation: University of California, San Diego
name: James D Murphy, MD
role: PRINCIPAL_INVESTIGATOR
References: