Histological or Cytological Diagnosis of Pancreatic Carcinoma
Conditions
Brief summary
Primary Objective: To estimate the rate at which radiotherapy to the primary or a metastatic lesion produces an immune response in patients with metastatic carcinoma of the pancreas. Secondary Objectives: To characterize the kinetics of an immune response induced by radiotherapy. To characterize the dependency of the immune response on prior exposure to chemotherapy.
Interventions
DEVICERadiation therapy
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological or cytological diagnosis of pancreatic carcinoma * Patients ≥ 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status 0,1,or 2 * Patients must have distant metastatic disease (stage 4) * Satisfactory organ and bone marrow function as defined by: Absolute neutrophil count\> 1,000/uL, Platelets \> 75,000uL Hemoglobin \> 9 Bilirubin ≤ 2.0x the institutional normal upper limit unless secondary to bile duct obstruction by tumor, * Creatinine ≤ 1.5x the institutional normal upper limit * Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5x the institutional normal upper limit. * A clinical recommendation for radiotherapy to the primary or a metastatic lesion had been made. * Must be able to provide informed consent.
Exclusion criteria
* No prior radiation to the area planned for radiotherapy * Active invasive cancer other than pancreatic adenocarcinoma. Non-melanoma skin cancer, superficial cervical or bladder cancer and prostate cancer with PSA level \< 1.0 are not excluded. * Known HIV, HCV and/or HBV positive (by patient report/medical record) * Patients with ongoing or active infection * Planned concurrent treatment with systemic high dose corticosteroids. * Received an anticancer treatment (systemic therapy or radiation therapy)within 21 days prior to enrollment. * Immunotherapy (e.g. monoclonal antibodies)within 21 days prior to enrollment. * Immunosuppressive therapies (e.g. steroids, cyclosporine) are not permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events | One Year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm In this trial, we will deliver low-dose (8Gy in a single fraction) radiotherapy (SBRT or any other acceptable delivery method as determined by the treating physician) for palliation of symptoms in patients in whom it is clinically indicated. This dose is far lower than what has been used in the definitive settings described above. This is a safe dose, and is entirely consistent with the dose range used for routine palliation. Therefore, this trial does not involve an experimental intervention; the research aspect of this protocol is the evaluation of the immune response to clinically indicated palliative radiotherapy.
Radiation therapy | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 69.1 years STANDARD_DEVIATION 17.22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 1 / 4 |
Outcome results
Primary
Number of Participants With Adverse Events
Time frame: One Year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Number of Participants With Adverse Events | 0 Participants |