Trial Outcomes & Findings for Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer (NCT NCT00350142)

NCT ID: NCT00350142

Last Updated: 2017-02-14

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: up to 3 years
• Results posted on: 2017-02-14

Participant Flow

Participant milestones

Measure	Stereotactic Body Radiotherapy patients that received a single fraction of 25 Gy Stereotactic Body Radiotherapy followed by weekly Gemcitabine administered at 1000mg/m2 over 100 minutes. Patients will be followed at 4-6 weeks, 3 months, 6 months, 9 months and 1 year, in year 2 follow up will be every 4 months and in year 3 follow up will be every 6 months.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer

Baseline characteristics by cohort

Measure	SBRT n=20 Participants 25 Gy single fraction dose using Trilogy linear accelerator
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=93 Participants
Age, Categorical >=65 years	9 Participants n=93 Participants
Age, Continuous	63 years n=93 Participants
Gender Female	11 Participants n=93 Participants
Gender Male	9 Participants n=93 Participants
Region of Enrollment United States	20 participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Stereotactic Radiosurgery n=20 Participants patients w/ pancreas Cancer receiving Stereotactic Radiosurgery and Gemcitabine
Rate of Local Control	15 participants Interval 0.0 to

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Stereotactic Radiosurgery n=20 Participants patients w/ pancreas Cancer receiving Stereotactic Radiosurgery and Gemcitabine
Median Overall Survival Time	11.8 months Interval 7.0 to 25.1

Adverse Events

SBRT With Gem

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	SBRT With Gem n=20 participants at risk patient with locally advanced pancreas cancer receiving Gem + SBRT
Gastrointestinal disorders Perforation	5.0% 1/20 • Number of events 1 • following SBRT, follow-up at 4-6 weeks, then every 3 months in year 1 and 4 months year 2.

Other adverse events

Measure	SBRT With Gem n=20 participants at risk patient with locally advanced pancreas cancer receiving Gem + SBRT
Gastrointestinal disorders pain	5.0% 1/20 • Number of events 1 • following SBRT, follow-up at 4-6 weeks, then every 3 months in year 1 and 4 months year 2.
Gastrointestinal disorders vomiting	10.0% 2/20 • Number of events 2 • following SBRT, follow-up at 4-6 weeks, then every 3 months in year 1 and 4 months year 2.
Gastrointestinal disorders ulcer	15.0% 3/20 • Number of events 3 • following SBRT, follow-up at 4-6 weeks, then every 3 months in year 1 and 4 months year 2.

Additional Information

Dr. Albert Koong

Stanford Cancer Center

Phone: 650-498-7703

Email: akoong@stanford.edu

Results disclosure agreements

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