Pancreatic Cancer
Conditions
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.
Interventions
RADIATIONSBRT
Fixed five-fraction stereotactic radiotherapy
Sponsors
University of California, San Diego
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 SBRT 40 Gy in 5 fractions
SBRT: Fixed five-fraction stereotactic radiotherapy | 3 |
| Cohort 2 SBRT 45 Gy in 5 fractions (starting dose level)
SBRT: Fixed five-fraction stereotactic radiotherapy | 16 |
| Cohort 3 SBRT 50 Gy in 5 fractions
SBRT: Fixed five-fraction stereotactic radiotherapy | 11 |
| Cohort 4 SBRT 55 Gy in 5 fractions
SBRT: Fixed five-fraction stereotactic radiotherapy | 0 |
| Cohort 5 SBRT 60 Gy in 5 fractions
SBRT: Fixed five-fraction stereotactic radiotherapy | 0 |
| Total | 30 |
Baseline characteristics
| Characteristic | Cohort 2 | Cohort 3 | Total | Cohort 1 |
|---|---|---|---|---|
| Age, Continuous | 70.3 years | 77.2 years | 72.9 years | 71.3 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United States | 16 participants | 11 participants | 30 participants | 3 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 12 Participants | 2 Participants |
| Sex: Female, Male Male | 11 Participants | 6 Participants | 18 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 3 | 16 / 16 | 11 / 11 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 3 | 0 / 16 | 0 / 11 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 2 / 16 | 0 / 11 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Maximum Tolerated Dose
The purpose of this study is to determine the maximum tolerated dose of five fraction stereotactic radiotherapy (SBRT) in pancreatic cancer.
Time frame: From date of randomization to observed dose limiting toxicity (DLT) in 20% of patients assessed up to 3 years
Population: Patients we're treated at 3 dose levels (40, 45, and 50 Gy). The dose-limiting toxicity for the study was 50 Gy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Maximum Tolerated Dose | 50 Gray |