Pancreatic Cancer
Conditions
Keywords
Stereotactic Body Radiotherapy (SBRT), pancreas cancer, locally advanced, local control, Gemcitabine
Brief summary
This study will assess the efficacy of treating locally advanced pancreatic cancer using Stereotactic Body Radiotherapy (using Trilogy) and Gemcitabine
Detailed description
In this study, we propose to combine stereotactic body radiotherapy (SBRT) with standard gemcitabine chemotherapy. We hypothesize that earlier administration of systemic chemotherapy may prolong the interval to distant progression and improve overall survival in these patients. In this study, we will treat pancreatic cancer patients with locally advanced disease with 3 weeks of gemcitabine, followed by Trilogy(TM) SBRT and additional gemcitabine. 30 patients will be accrued to this study at Stanford University Medical Center, the only site participating in this research study. Treatment on this protocol requires placement of 3-5 gold (99.9% pure) fiducials for targeting purposes. Four to 7 days after placement of the fiducials, patients will then undergo a 4D pancreatic protocol CT scan through the upper abdomen. In addition, an FDG PET scan is required for treatment planning purposes. This imaging set will be processed for radiosurgery, using a modified linac based radiation treatment planning system (EclipseTM). An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy prescribed to the isodose line that completely surrounds the gross pancreatic tumor volume (GTV) as defined by the contrast CT. Following SBRT, patients will be monitored clinically and radiographically.
Interventions
RADIATIONStereotactic Body Radiotherapy
Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator
DRUGGemcitabine
Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes
OTHER4D pancreatic protocol CT scan
Patients will undergo this imaging procedure prior to treatment for planning purposes.
RADIATIONFDG PET scan
Patients will have this imaging procedure along with a CT scan to map the tumor and facilitate treatment planning.
Sponsors
Albert Koong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
- Pancreatic tumors not to exceed 10 cm in greatest axial dimension * Histologically confirmed malignancies of the pancreas * Unresectable by CT criteria or exploratory laparotomy or laparoscopy * Patients with metastatic disease may be treated if they are symptomatic from the primary tumor * Performance status of 0, 1, or 2 * No chemotherapy two weeks prior or two weeks following radiosurgery
Exclusion criteria
* patients who have had prior radiotherapy to upper abdomen * patients receiving any prior pancreatic cancer therapy * children, pregnant, and breastfeeding women, and lab personnel are excluded * uncontrolled intercurrent illnesses * any concurrent malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Local Control | up to 3 years | The proportion of patients with local control where local control is defined as no recurrence or disease progression in the primary disease site. Disease progression was defined using either the RECIST or Pet criteria. Using the RECIST criteria disease progression is defined as a more than 25% tumor increase by volume and/ or presence of a new lesion. Using the Pet criteria disease progression is defined as an increase in PET activity as compared to the scan used in the planning of the treatment; any subsequent increase in SUVmax was defined as local progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Overall Survival Time | up to 3 years | The survival time for each patient is measured as the number of months from randomization until the time of death from any cause. The median survival time is computed using Kaplan Meier curves. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SBRT 25 Gy single fraction dose using Trilogy linear accelerator | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | SBRT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 63 years |
| Gender Female | 11 Participants |
| Gender Male | 9 Participants |
| Region of Enrollment United States | 20 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
Primary
Rate of Local Control
The proportion of patients with local control where local control is defined as no recurrence or disease progression in the primary disease site. Disease progression was defined using either the RECIST or Pet criteria. Using the RECIST criteria disease progression is defined as a more than 25% tumor increase by volume and/ or presence of a new lesion. Using the Pet criteria disease progression is defined as an increase in PET activity as compared to the scan used in the planning of the treatment; any subsequent increase in SUVmax was defined as local progression.
Time frame: up to 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stereotactic Radiosurgery | Rate of Local Control | 15 participants |
Secondary
Median Overall Survival Time
The survival time for each patient is measured as the number of months from randomization until the time of death from any cause. The median survival time is computed using Kaplan Meier curves.
Time frame: up to 3 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stereotactic Radiosurgery | Median Overall Survival Time | 11.8 months |