Trial Outcomes & Findings for Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer (NCT NCT01346410)

Results Overview

Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of \> 20% in tumor size. If necessary, a Positron Emission Tomography scan may be used to aid in diagnoses of local tumor recurrence.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

5 years

Results posted on

2020-02-19

Participant Flow

Participant milestones

Participant milestones
Measure	Stereotactic Radiation to Pancreas Stereotactic Radiation to Pancreas Stereotactic Body Radiotherapy: Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Stereotactic Radiation to Pancreas Stereotactic Radiation to Pancreas Stereotactic Body Radiotherapy: Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)
Overall Study Death	1

Baseline Characteristics

Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stereotactic Radiation to Pancreas n=1 Participants Stereotactic Radiation to Pancreas Stereotactic Body Radiotherapy: Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)
Age, Continuous	79 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of \> 20% in tumor size. If necessary, a Positron Emission Tomography scan may be used to aid in diagnoses of local tumor recurrence.

Outcome measures

Outcome measures
Measure	Stereotactic Radiation to Pancreas n=1 Participants Stereotactic Radiation to Pancreas Stereotactic Body Radiotherapy: Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)
Local Control Rate	1 Participants

SECONDARY outcome

Timeframe: 5 years

Population: This outcome was not collected as planned.

Toxicities will be graded using CTCAE criteria at specified timepoints.

Outcome measures

Outcome data not reported

Adverse Events

Stereotactic Radiation to Pancreas

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Kathy Baglan

Mercy

Phone: 3144345886

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place