Trial Outcomes & Findings for Neoadjuvant Stereotactic Body Radiation Therapy for Resectable Adenocarcinoma of the Pancreatic Head and/or Body (NCT NCT02208024)

NCT ID: NCT02208024

Last Updated: 2022-04-29

Results Overview

AEs were reviewed for gastrointestinal toxicity. Toxicities of note include grade 3 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2022-04-29

Participant Flow

Participant milestones

Measure	Stereotactic Body Radiation Therapy 5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days Stereotactic Body Radiation Therapy
Overall Study STARTED	18
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Stereotactic Body Radiation Therapy 5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days Stereotactic Body Radiation Therapy
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Neoadjuvant Stereotactic Body Radiation Therapy for Resectable Adenocarcinoma of the Pancreatic Head and/or Body

Baseline characteristics by cohort

Measure	Stereotactic Body Radiation Therapy n=17 Participants 5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days Stereotactic Body Radiation Therapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 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	1 Participants n=5 Participants
Race (NIH/OMB) White	16 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	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

AEs were reviewed for gastrointestinal toxicity. Toxicities of note include grade 3 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity.

Outcome measures

Measure	Stereotactic Body Radiation Therapy n=17 Participants 5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days Stereotactic Body Radiation Therapy
Number of Participants With Acute (Within 3 Months of Treatment) Grade 3 or Greater Gastrointestinal Toxicity	0 Participants

SECONDARY outcome

Timeframe: 1 year

AEs were assessed for gastrointestinal toxicity. Toxicities of note include grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity.

Outcome measures

Measure	Stereotactic Body Radiation Therapy n=17 Participants 5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days Stereotactic Body Radiation Therapy
Number of Participants With Late (Greater Than 3 Months After Treatment) Grade 2 Gastritis, Enteritis, Fistula, and Ulcer or Any Other Grade 3 or Greater Gastrointestinal Toxicity	0 Participants

SECONDARY outcome

Timeframe: 1 year

Local tumor progression will be defined as >=20% increased size on CT scan compared to a CT. scan from prior to treatment. Distant progression will be defined as any new tumor found outside of the pancreas or periampullary region on CT scan. Local and/or distant progression will be evaluated by both PET/CT (if available) and CT scan as deemed by treating physician.

Outcome measures

Measure	Stereotactic Body Radiation Therapy n=17 Participants 5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days Stereotactic Body Radiation Therapy
Local Progression Free Survival	13 Participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Stereotactic Body Radiation Therapy n=17 Participants 5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days Stereotactic Body Radiation Therapy
Metastasis Free Survival	11 Participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Stereotactic Body Radiation Therapy n=17 Participants 5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days Stereotactic Body Radiation Therapy
Overall Survival	14 Participants

Adverse Events

Stereotactic Body Radiation Therapy

Serious events: 2 serious events

Other events: 8 other events

Deaths: 11 deaths

Serious adverse events

Measure	Stereotactic Body Radiation Therapy n=17 participants at risk 5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days Stereotactic Body Radiation Therapy
Vascular disorders Thromboembolic event	5.9% 1/17 • Number of events 2 • AEs will be collected up to 12 months after the start of treatment. The definition does not differ from the definitions used from the clinicaltrial.gov definitions.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	5.9% 1/17 • Number of events 1 • AEs will be collected up to 12 months after the start of treatment. The definition does not differ from the definitions used from the clinicaltrial.gov definitions.

Other adverse events

Measure	Stereotactic Body Radiation Therapy n=17 participants at risk 5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days Stereotactic Body Radiation Therapy
Gastrointestinal disorders Abdominal distension	5.9% 1/17 • Number of events 1 • AEs will be collected up to 12 months after the start of treatment. The definition does not differ from the definitions used from the clinicaltrial.gov definitions.
Skin and subcutaneous tissue disorders Alopecia	5.9% 1/17 • Number of events 1 • AEs will be collected up to 12 months after the start of treatment. The definition does not differ from the definitions used from the clinicaltrial.gov definitions.
Infections and infestations Appendicitis perforated	5.9% 1/17 • Number of events 1 • AEs will be collected up to 12 months after the start of treatment. The definition does not differ from the definitions used from the clinicaltrial.gov definitions.
Investigations Blood bilirubin increased	5.9% 1/17 • Number of events 1 • AEs will be collected up to 12 months after the start of treatment. The definition does not differ from the definitions used from the clinicaltrial.gov definitions.
Gastrointestinal disorders Constipation	5.9% 1/17 • Number of events 1 • AEs will be collected up to 12 months after the start of treatment. The definition does not differ from the definitions used from the clinicaltrial.gov definitions.
Metabolism and nutrition disorders Dehydration	5.9% 1/17 • Number of events 1 • AEs will be collected up to 12 months after the start of treatment. The definition does not differ from the definitions used from the clinicaltrial.gov definitions.
Nervous system disorders Dizziness	5.9% 1/17 • Number of events 1 • AEs will be collected up to 12 months after the start of treatment. The definition does not differ from the definitions used from the clinicaltrial.gov definitions.
General disorders Fatigue	5.9% 1/17 • Number of events 1 • AEs will be collected up to 12 months after the start of treatment. The definition does not differ from the definitions used from the clinicaltrial.gov definitions.
Infections and infestations Infections and infestations - Other, specify	5.9% 1/17 • Number of events 1 • AEs will be collected up to 12 months after the start of treatment. The definition does not differ from the definitions used from the clinicaltrial.gov definitions.
Gastrointestinal disorders Nausea	11.8% 2/17 • Number of events 2 • AEs will be collected up to 12 months after the start of treatment. The definition does not differ from the definitions used from the clinicaltrial.gov definitions.
Infections and infestations Upper respiratory infection	5.9% 1/17 • Number of events 1 • AEs will be collected up to 12 months after the start of treatment. The definition does not differ from the definitions used from the clinicaltrial.gov definitions.
Infections and infestations Urinary tract infection	5.9% 1/17 • Number of events 1 • AEs will be collected up to 12 months after the start of treatment. The definition does not differ from the definitions used from the clinicaltrial.gov definitions.
Gastrointestinal disorders Vomiting	5.9% 1/17 • Number of events 1 • AEs will be collected up to 12 months after the start of treatment. The definition does not differ from the definitions used from the clinicaltrial.gov definitions.
Investigations Weight loss	5.9% 1/17 • Number of events 1 • AEs will be collected up to 12 months after the start of treatment. The definition does not differ from the definitions used from the clinicaltrial.gov definitions.

Additional Information

Jordan Kharofa, Associate Professor, Department of Radiation Oncology

University of Cincinnati Cancer Center

Phone: (513)-584-4073

Email: kharofjr@ucmail.uc.edu

Results disclosure agreements

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