CompletedNCT01985958Updated Apr 20, 2020Results posted

A Pilot Study to Evaluate Radiotherapy-Induced Anti-Tumor Immunity in Metastatic Carcinoma of the Pancreas

An interventional study of Radiation therapy in Histological or Cytological Diagnosis of Pancreatic Carcinoma, sponsored by Abramson Cancer Center at Penn Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-20.

Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Diagnostic

Phase: Not applicable
Study type: Interventional
Enrollment: 4
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Histological or Cytological Diagnosis of Pancreatic Carcinoma

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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 4 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

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Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts 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

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.

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Enrollment: 4 participants (actual)

Study arms

Experimental
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.
Device: Radiation therapy

Interventions

DeviceRadiation therapy

What researchers measure

Primary outcomes

Number of Participants With Adverse Events
Time frame: One Year

Results

Posted Nov 5, 2019

Participant flow

Participant flow — Overall Study
Milestone	Single Arm
Started	4
Completed	3
Not completed	1

Outcome measures

PrimaryNumber of Participants With Adverse Events

Time frame:: One Year
Reported as:: Count of participants · Participants

Number of Participants With Adverse Events
Participants	Single Arm
Number of Participants With Adverse Events	0

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Single Arm	1/4 (25%)	1/4 (25%)	0/4 (0%)

Most frequent serious events

Most frequent serious events
Event	Single Arm
Death NOSGeneral disorders	1/4

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Single Arm
<=18 years	0
Between 18 and 65 years	1
>=65 years	3

Age, Continuous
Age, Continuous(years)	Single Arm
Mean	69.1 ± 17.22

Sex: Female, Male
Sex: Female, Male(Participants)	Single Arm
Female	2
Male	2

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Single Arm
Hispanic or Latino	0
Not Hispanic or Latino	4
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Single Arm
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	4
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	Single Arm
United States	4

Study locations

1 site

Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01985958
Lead sponsor: Abramson Cancer Center at Penn Medicine
Responsible party: Sponsor
First posted: Nov 18, 2013
Start date: Jul 2013
Primary completion: Sep 2015
Completion: Dec 2019
Results posted: Nov 5, 2019
Last update: Apr 20, 2020

Study contacts

Edgar Ben-Josef, MD

principal investigator · Abramson Cancer Center at Penn Medicine

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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