Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

Phase II Study to Evaluate Stereotactic Body Radiation Therapy For Palliative Management of Unresectable Recurrent or Residual Pancreatic or Periampullary Adenocarcinoma

The investigators are looking to see if a certain dose of stereotactic body radiation therapy (SBRT) may be a viable treatment option for recurrent or residual pancreatic or periampullary adenocarcinoma.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Periampullary Adenocarcinoma
• Intervention / Treatment: Radiation: Stereotactic Body Radiation Therapy (SBRT)

Detailed Description

No standard treatment option has yet been established for patients with recurrent or residual disease after definitive treatment of pancreatic or periampullary cancers (duodenal, ampullary, bile duct). Linac based stereotactic body radiation therapy (SBRT) administered in 1-3 fractions has been shown to be an effective treatment option for patients with unresectable, locally advanced pancreatic adenocarcinoma, achieving local control rates of 84-92% at one year. Associated late gastrointestinal toxicity rates have been reported to be 22-25% at 1 year. We hypothesize that similarly excellent local control rates (80-90% at one year) with a reasonable rate of toxicity (≤20%) can be achieved using Linac based SBRT delivered as 5 Gy x 5 for patients with local failure (remaining disease) after previous treatment with conventional chemoradiation therapy (CRT) with or without surgery and as 6.6 Gy x 5 for radiation-naïve patients with local failure (remaining disease) after previous treatment with surgery and/or chemotherapy. The toxicities of note for this trial are grade 2 and greater gastritis, fistula, enteritis, ulcer, or any other grade 3 or greater gastrointestinal toxicity.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age or older
• Karnofsky Performance Status greater than or equal to 70%
• confirmed pancreatic or periampullary adenocarcinoma
• pancreatic or periampullary tumor less than 8.0 cm in greatest axial dimension

• Either:

  • standard of care treatment for pancreatic cancer that included radiation therapy

    * patients may be receiving continued chemotherapy post initial CRT. or

  • standard of care treatment for pancreatic cancer that did not include radiation therapy * patients must have attempted chemotherapy upon initial diagnosis
• acceptable organ and marrow function as determined by blood tests
• ability to understand and give consent
• must be a patient to be treated with SBRT only at Johns Hopkins Hospital
• life expectancy of greater than 3 months

Exclusion Criteria:

• extensive metastatic disease
• performance status of less than 70
• children are excluded form the study
• no uncontrolled intercurrent illness
• no concurrent malignancy other than melanoma
• pregnant or breast feeding women are excluded
• women who are not post-menopausal and have a positive pregnancy test
• life expectancy of less than 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Radiation: Stereotactic Body Radiation Therapy (SBRT); Stereotactic Body Radiation Therapy (SBRT) which included 5 consecutive fractions of 25 to 33 Gy, following 3 months of multiagent chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late Gastrointestinal Toxicities	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.	3 months post-treatment to date of first progression or date of death, whichever comes first assessed up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Gastrointestinal Toxicity	Any acute gastrointestinal (GI) toxicities grade 3 or greater.	within 3 months of treatment
Local Progression Free Survival From SBRT	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.	From date of randomization until the date of first documented progression or death from any cause (up to 36 months).
Local Progression Free Survival From Diagnosis	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.	From date documented diagnosis to date of first documented local disease progression.
Change in Patient Reported Quality of Life (PR-QOL) Assessment at Baseline (Pre-treatment) and 3 Months (Post-Treatment)	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.	Baseline (Pre-SBRT) and at 3 months (Post-SBRT)
Linac Based SBRT Standardization	To develop and standardize Linac based SBRT delivery and dosimetric parameters	3, 6, and 12 months after treatment
FDG-PET Use for Planning and Estimation of Survival	To evaluate the utility of FDG-PET for treatment planning and estimation of progression-free survival.	3, 6, and 12 months after treatment and then annually thereafter
Linear Accelerator (Linac) Based SBRT Pain Control	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.	3, 6, and 12 months after treatment
Toxicity for Patients With Chemotherapy, Surgery (Resection) and Radiation for Tumor Assessments	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.	Up to 36 months
Toxicity for Patients With 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.	Up to 36 months

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Investigators: Principal Investigator: Amol Narang, M.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: August 8, 2012
• First Submitted That Met QC Criteria: January 30, 2013
• First Posted (Estimated): February 1, 2013

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: recurrent; unresectable; residual; stereotactic body radiation therapy (SBRT); palliative management
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma
• Other Study ID Numbers: J1273; NA_00070233 (Other Identifier: JHMIRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO