Trial Outcomes & Findings for Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer (NCT NCT01342354)

NCT ID: NCT01342354

Last Updated: 2025-07-18

Results Overview

Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2025-07-18

Participant Flow

Excluded Patients (n = 2) due to screening failures

Participant milestones

Measure	Stereotactic Radiation: 10 Gy x3 Level 1 - SBRT 10Gy in three doses over ten days (total 30 Gy).	Stereotactic Radiation: 12.5 Gy x3 Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy).	Stereotactic Radiation: 15 Gy x3 Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy).
Overall Study STARTED	3	3	9
Overall Study COMPLETED	3	3	9
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer

Baseline characteristics by cohort

Measure	Stereotactic Radiation: 10 Gy x3 n=3 Participants Level 1 - SBRT 10Gy in three doses over ten days (total 30 Gy).	Stereotactic Radiation: 12.5 Gy x3 n=3 Participants Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy).	Stereotactic Radiation: 15 Gy x3 n=9 Participants Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy).	Total n=15 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	55 years n=7 Participants	61 years n=5 Participants	61 years n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants	15 participants n=4 Participants

PRIMARY outcome

Timeframe: 28 days

Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation.

Outcome measures

Measure	Stereotactic Radiation n=15 Participants All participants received one course of SBRT	Stereotactic Radiation: 12.5 Gy x3 Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy).	Stereotactic Radiation: 15 Gy x3 Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy).
Maximum Tolerated Dose (Phase 1)	45 Gy	—	—

SECONDARY outcome

Timeframe: 12 months after treatment

Grade 3+ GI late toxicity

Outcome measures

Measure	Stereotactic Radiation n=3 Participants All participants received one course of SBRT	Stereotactic Radiation: 12.5 Gy x3 n=3 Participants Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy).	Stereotactic Radiation: 15 Gy x3 n=9 Participants Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy).
The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity	2 participants	0 participants	2 participants

SECONDARY outcome

Timeframe: 12 months after treatment

Population: Only eight patients of enrolled patients across all dose levels had pain at presentation and were eligible for this secondary outcome of pain response

Using the visual analog scale, patients rate pain from 1-10 with higher scores indicate greater pain intensity. Improvement in pain is defined as a yes/no response.

Outcome measures

Measure	Stereotactic Radiation n=3 Participants All participants received one course of SBRT	Stereotactic Radiation: 12.5 Gy x3 Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy).	Stereotactic Radiation: 15 Gy x3 n=5 Participants Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy).
Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale	3 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 12 months after treatment

Outcome measures

Measure	Stereotactic Radiation n=3 Participants All participants received one course of SBRT	Stereotactic Radiation: 12.5 Gy x3 n=3 Participants Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy).	Stereotactic Radiation: 15 Gy x3 n=9 Participants Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy).
Number of Patients Eligible for Surgery to Remove Tumor After Treatment	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 12 months after treatment

Number of patients with no disease progression as measured by tumor imaging, based on RECIST criteria

Outcome measures

Measure	Stereotactic Radiation n=3 Participants All participants received one course of SBRT	Stereotactic Radiation: 12.5 Gy x3 n=3 Participants Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy).	Stereotactic Radiation: 15 Gy x3 n=9 Participants Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy).
Number of Patients With Local Disease Control	3 participants	3 participants	5 participants

SECONDARY outcome

Timeframe: 12 months after treatment

Population: This measure was added to the study protocol when accrual for the third cohort began and thus was only assessed in the third (15 Gy x3) cohort. Among this cohort, baseline data was only collected for 5 patients and only 1 of these patients had 12 month data, which was optional, and that is what is summarized here.

The Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) is an instrument that assesses health-related quality of life in patients with hepatobiliary cancers. The FACT-Hep consists of the FACT-G, which assesses generic health-related quality of life and concerns, and a validated Hepatobiliary Subscale (HS), which assesses disease-specific issues. Responses are on a 5 point Likert-type scale; items are summed to generate scores, with higher scores indicating better QOL (possible range of total score = 0-180).

Outcome measures

Measure	Stereotactic Radiation All participants received one course of SBRT	Stereotactic Radiation: 12.5 Gy x3 Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy).	Stereotactic Radiation: 15 Gy x3 n=5 Participants Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy).
Change From Baseline in Patient Reported Outcomes Using FACT-Hepatobiliary (FACT-Hep) Quality of Life Questionnaire. Baseline	—	—	142 score on a scale Standard Deviation 24
Change From Baseline in Patient Reported Outcomes Using FACT-Hepatobiliary (FACT-Hep) Quality of Life Questionnaire. 12 months	—	—	157 score on a scale Standard Deviation 0

Adverse Events

Stereotactic Radiation: 10 Gy x3

Serious events: 2 serious events

Other events: 1 other events

Deaths: 3 deaths

Stereotactic Radiation: 12.5 Gy x3

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Stereotactic Radiation: 15 Gy x3

Serious events: 2 serious events

Other events: 7 other events

Deaths: 9 deaths

Serious adverse events

Measure	Stereotactic Radiation: 10 Gy x3 n=3 participants at risk Level 1 - SBRT 10Gy in three doses over ten days (total 30 Gy).	Stereotactic Radiation: 12.5 Gy x3 n=3 participants at risk Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy).	Stereotactic Radiation: 15 Gy x3 n=9 participants at risk Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy).
Gastrointestinal disorders Gastrointestinal bleeding	66.7% 2/3 • Adverse events as specified in the protocol to meet the definition of dose-limiting toxicity or acute adverse events were monitored for only one month. Serious adverse events ( late GI toxicity) were followed for up to 12 months after treatment. All-cause mortality was assessed over a longer period, which in this case was until death for all enrolled patients and up to 8 years.	0.00% 0/3 • Adverse events as specified in the protocol to meet the definition of dose-limiting toxicity or acute adverse events were monitored for only one month. Serious adverse events ( late GI toxicity) were followed for up to 12 months after treatment. All-cause mortality was assessed over a longer period, which in this case was until death for all enrolled patients and up to 8 years.	22.2% 2/9 • Adverse events as specified in the protocol to meet the definition of dose-limiting toxicity or acute adverse events were monitored for only one month. Serious adverse events ( late GI toxicity) were followed for up to 12 months after treatment. All-cause mortality was assessed over a longer period, which in this case was until death for all enrolled patients and up to 8 years.

Other adverse events

Measure	Stereotactic Radiation: 10 Gy x3 n=3 participants at risk Level 1 - SBRT 10Gy in three doses over ten days (total 30 Gy).	Stereotactic Radiation: 12.5 Gy x3 n=3 participants at risk Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy).	Stereotactic Radiation: 15 Gy x3 n=9 participants at risk Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy).
Gastrointestinal disorders Nausea	33.3% 1/3 • Adverse events as specified in the protocol to meet the definition of dose-limiting toxicity or acute adverse events were monitored for only one month. Serious adverse events ( late GI toxicity) were followed for up to 12 months after treatment. All-cause mortality was assessed over a longer period, which in this case was until death for all enrolled patients and up to 8 years.	100.0% 3/3 • Adverse events as specified in the protocol to meet the definition of dose-limiting toxicity or acute adverse events were monitored for only one month. Serious adverse events ( late GI toxicity) were followed for up to 12 months after treatment. All-cause mortality was assessed over a longer period, which in this case was until death for all enrolled patients and up to 8 years.	44.4% 4/9 • Adverse events as specified in the protocol to meet the definition of dose-limiting toxicity or acute adverse events were monitored for only one month. Serious adverse events ( late GI toxicity) were followed for up to 12 months after treatment. All-cause mortality was assessed over a longer period, which in this case was until death for all enrolled patients and up to 8 years.
General disorders Fatigue	0.00% 0/3 • Adverse events as specified in the protocol to meet the definition of dose-limiting toxicity or acute adverse events were monitored for only one month. Serious adverse events ( late GI toxicity) were followed for up to 12 months after treatment. All-cause mortality was assessed over a longer period, which in this case was until death for all enrolled patients and up to 8 years.	33.3% 1/3 • Adverse events as specified in the protocol to meet the definition of dose-limiting toxicity or acute adverse events were monitored for only one month. Serious adverse events ( late GI toxicity) were followed for up to 12 months after treatment. All-cause mortality was assessed over a longer period, which in this case was until death for all enrolled patients and up to 8 years.	55.6% 5/9 • Adverse events as specified in the protocol to meet the definition of dose-limiting toxicity or acute adverse events were monitored for only one month. Serious adverse events ( late GI toxicity) were followed for up to 12 months after treatment. All-cause mortality was assessed over a longer period, which in this case was until death for all enrolled patients and up to 8 years.
Gastrointestinal disorders Gastrointestinal bleeding	0.00% 0/3 • Adverse events as specified in the protocol to meet the definition of dose-limiting toxicity or acute adverse events were monitored for only one month. Serious adverse events ( late GI toxicity) were followed for up to 12 months after treatment. All-cause mortality was assessed over a longer period, which in this case was until death for all enrolled patients and up to 8 years.	0.00% 0/3 • Adverse events as specified in the protocol to meet the definition of dose-limiting toxicity or acute adverse events were monitored for only one month. Serious adverse events ( late GI toxicity) were followed for up to 12 months after treatment. All-cause mortality was assessed over a longer period, which in this case was until death for all enrolled patients and up to 8 years.	11.1% 1/9 • Adverse events as specified in the protocol to meet the definition of dose-limiting toxicity or acute adverse events were monitored for only one month. Serious adverse events ( late GI toxicity) were followed for up to 12 months after treatment. All-cause mortality was assessed over a longer period, which in this case was until death for all enrolled patients and up to 8 years.

Additional Information

Dr. Stanley Liauw

The University of Chicago

Phone: (773) 702-0817

Email: Stanley.Liauw@uchospitals.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place