Trial Outcomes & Findings for Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma (NCT NCT01781728)

NCT ID: NCT01781728

Last Updated: 2025-07-20

Results Overview

Late (Up to 3 months post-treatment to date of first progression or date of death, (whichever comes first-up to 36 months) Grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity attributable to Stereotactic Body Radiation Therapy (SBRT). Toxicity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 4.0) and the Radiation Therapy Oncology Group radiation morbidity scoring criteria.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: 3 months post-treatment to date of first progression or date of death, whichever comes first assessed up to 36 months
• Results posted on: 2025-07-20

Participant Flow

Participant milestones

Measure	Locally Advanced Pancreatic Cancer or Locally Recurrent Pancreatic Ductal Adenocarcinoma Patients with pathologically confirmed, locally advanced pancreatic ductal adenocarcinoma (LAPC), unresectable at diagnosis, or local recurrence pancreatic ductal adenocarcinoma (PDAC) after prior surgical resection.
Overall Study STARTED	48
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Locally Advanced Pancreatic Cancer or Locally Recurrent Pancreatic Ductal Adenocarcinoma n=48 Participants Patients with pathologically confirmed, locally advanced pancreatic ductal adenocarcinoma (LAPC), unresectable at diagnosis, or local recurrence pancreatic ductal adenocarcinoma (PDAC) after prior surgical resection.
Age, Categorical <=18 years	0 Participants n=48 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=48 Participants
Age, Categorical >=65 years	33 Participants n=48 Participants
Sex: Female, Male Female	17 Participants n=48 Participants
Sex: Female, Male Male	31 Participants n=48 Participants

PRIMARY outcome

Timeframe: 3 months post-treatment to date of first progression or date of death, whichever comes first assessed up to 36 months

Late (Up to 3 months post-treatment to date of first progression or date of death, (whichever comes first-up to 36 months) Grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity attributable to Stereotactic Body Radiation Therapy (SBRT).

Toxicity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 4.0) and the Radiation Therapy Oncology Group radiation morbidity scoring criteria.

Outcome measures

Measure	Locally Advanced Pancreatic Cancer or Locally Recurrent Pancreatic Ductal Adenocarcinoma n=48 Participants Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy x 5 (over 1-2 weeks)\*
Late Gastrointestinal Toxicities	13 Participants

SECONDARY outcome

Timeframe: within 3 months of treatment

Any acute gastrointestinal (GI) toxicities grade 3 or greater.

Outcome measures

Measure	Locally Advanced Pancreatic Cancer or Locally Recurrent Pancreatic Ductal Adenocarcinoma n=48 Participants Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy x 5 (over 1-2 weeks)\*
Acute Gastrointestinal Toxicity	3 Participants

SECONDARY outcome

Timeframe: From date of randomization until the date of first documented progression or death from any cause (up to 36 months).

Local progression free survival defined as the length of time (months) during and after the treatment of a disease that a patient lives with cancer, but the disease does not worsen.

Outcome measures

Measure	Locally Advanced Pancreatic Cancer or Locally Recurrent Pancreatic Ductal Adenocarcinoma n=48 Participants Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy x 5 (over 1-2 weeks)\*
Local Progression Free Survival From SBRT	14.6 Months until local progression Interval 11.6 to 23.0

SECONDARY outcome

Timeframe: From date documented diagnosis to date of first documented local disease progression.

Local progression free survival defined as the length of time (months) during and after the treatment of a disease that a patient lives with cancer, but the disease does not worsen.

Outcome measures

Measure	Locally Advanced Pancreatic Cancer or Locally Recurrent Pancreatic Ductal Adenocarcinoma n=48 Participants Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy x 5 (over 1-2 weeks)\*
Local Progression Free Survival From Diagnosis	21.6 Months until local progression Interval 16.0 to 29.7

SECONDARY outcome

Timeframe: Baseline (Pre-SBRT) and at 3 months (Post-SBRT)

Population: Not all patients completed the QOL assessments. In this case 43 of the 48 patients completed assessments.

To evaluate whether a change in patient reported quality of life (QoL) occurred between baseline (pre-SBRT) and at 3 months (post-SBRT) using the European Organization for Research and Treatment in Cancer quality of life core cancer questionnaire with the pancreatic cancer module (EORTC QLQ-C30/Pan26). This assessment is a multi-dimensional, 30-item questionnaire which assesses 5 functional scales (physical, role, cognitive, emotional and social), 3 symptom scales ( fatigue, pain and nausea/vomiting), a global health/QoL scale as well as 6 single items. There are also 26 questions specific to patients with pancreatic cancer.

Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.

Outcome measures

Measure	Locally Advanced Pancreatic Cancer or Locally Recurrent Pancreatic Ductal Adenocarcinoma n=43 Participants Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy x 5 (over 1-2 weeks)\*
Change in Patient Reported Quality of Life (PR-QOL) Assessment at Baseline (Pre-treatment) and 3 Months (Post-Treatment)	0 score on a scale Interval -10.0 to 10.0

SECONDARY outcome

Timeframe: 3, 6, and 12 months after treatment

Population: We prioritized collecting and analyzing data for the primary outcome of this study which is reported in ClinicalTrials.gov. Unfortunately, due to lack of funding, we were not able to collect and analyze all secondary outcome data as planned.

To evaluate the ability of Linac based SBRT to provide pain control among symptomatic patients as measured by pain medication requirement at 3, 6 and 12 months after treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3, 6, and 12 months after treatment

Population: We prioritized collecting and analyzing data for the primary outcome of this study which is reported in ClinicalTrials.gov. Unfortunately, due to lack of funding, we were not able to collect and analyze all secondary outcome data as planned. Therefore, dosimetric parameters were not developed

To develop and standardize Linac based SBRT delivery and dosimetric parameters

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3, 6, and 12 months after treatment and then annually thereafter

Population: We prioritized collecting and analyzing data for the primary outcome of this study which is reported in ClinicalTrials.gov. Unfortunately, due to lack of funding, we were not able to collect and analyze all secondary outcome data as planned.

To evaluate the utility of FDG-PET for treatment planning and estimation of progression-free survival.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 36 months

Population: Participants who had chemotherapy, surgery (resection) and radiation.

Toxicity was assessed for grade ≥2 gastrointestinal toxic effects using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0) and the Radiation Therapy Oncology Group radiation morbidity scoring criteria.

Outcome measures

Measure	Locally Advanced Pancreatic Cancer or Locally Recurrent Pancreatic Ductal Adenocarcinoma n=13 Participants Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy x 5 (over 1-2 weeks)\*
Toxicity for Patients With Chemotherapy, Surgery (Resection) and Radiation for Tumor Assessments	6 Participants

SECONDARY outcome

Timeframe: Up to 36 months

Population: Participants who had chemotherapy and radiation (no resection)

Toxicity was assessed for grade ≥2 gastrointestinal toxic effects using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0) and the Radiation Therapy Oncology Group radiation morbidity scoring criteria.

Outcome measures

Measure	Locally Advanced Pancreatic Cancer or Locally Recurrent Pancreatic Ductal Adenocarcinoma n=13 Participants Stereotactic Body Radiation Therapy (SBRT): 6.6 Gy x 5 (over 1-2 weeks)\*
Toxicity for Patients With Chemotherapy and Radiation (no Resection)	7 Participants

Adverse Events

Locally Advanced Pancreatic Cancer or Locally Recurrent Pancreatic Ductal Adenocarcinoma

Serious events: 10 serious events

Other events: 3 other events

Deaths: 45 deaths

Serious adverse events

Measure	Locally Advanced Pancreatic Cancer or Locally Recurrent Pancreatic Ductal Adenocarcinoma n=48 participants at risk Patients with pathologically confirmed, locally advanced pancreatic ductal adenocarcinoma (LAPC), unresectable at diagnosis, or local recurrence pancreatic ductal adenocarcinoma (PDAC) after prior surgical resection.
Gastrointestinal disorders Duadenal Ulcer	2.1% 1/48 • Number of events 1 • Up to 36 months
Hepatobiliary disorders Liver Abcess	2.1% 1/48 • Number of events 3 • Up to 36 months
Hepatobiliary disorders Enteritis	2.1% 1/48 • Number of events 1 • Up to 36 months
Gastrointestinal disorders Bowel Obstruction	2.1% 1/48 • Number of events 1 • Up to 36 months
Infections and infestations Sepsis	2.1% 1/48 • Number of events 1 • Up to 36 months
Gastrointestinal disorders Gastrointestinal Bleed	2.1% 1/48 • Number of events 1 • Up to 36 months
General disorders Vomiting/Pain	2.1% 1/48 • Number of events 1 • Up to 36 months
Gastrointestinal disorders Biliary Obstruction	2.1% 1/48 • Number of events 1 • Up to 36 months
Gastrointestinal disorders Fistula	2.1% 1/48 • Number of events 1 • Up to 36 months

Other adverse events

Measure	Locally Advanced Pancreatic Cancer or Locally Recurrent Pancreatic Ductal Adenocarcinoma n=48 participants at risk Patients with pathologically confirmed, locally advanced pancreatic ductal adenocarcinoma (LAPC), unresectable at diagnosis, or local recurrence pancreatic ductal adenocarcinoma (PDAC) after prior surgical resection.
Gastrointestinal disorders Ulcer	2.1% 1/48 • Number of events 1 • Up to 36 months
Gastrointestinal disorders Enteritis	2.1% 1/48 • Number of events 1 • Up to 36 months
Gastrointestinal disorders Bowel Obstruction	2.1% 1/48 • Number of events 1 • Up to 36 months

Additional Information

Dr. Amol Narang

Johns Hopkins University, Department of Radiation Oncology

Phone: 410-913-3559

Email: anarang2@jhmi.edu

Results disclosure agreements

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