Trial Outcomes & Findings for A Pilot Study to Evaluate Radiotherapy-Induced Anti-Tumor Immunity in Metastatic Carcinoma of the Pancreas (NCT NCT01985958)

NCT ID: NCT01985958

Last Updated: 2020-04-20

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

One Year

Results posted on

2020-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=4 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	69.1 years STANDARD_DEVIATION 17.22 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: One Year

Outcome measures

Outcome measures
Measure	Single Arm n=4 Participants 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
Number of Participants With Adverse Events	0 Participants

Adverse Events

Single Arm

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=4 participants at risk 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
General disorders Death NOS	25.0% 1/4 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Edgar Ben-Josef, M.D.

University of Pennsylvania

Phone: 215-662-3932

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place