Palliative Stereotactic Radiation For Pancreatic Or Periampullary Adenocarcinoma

Study Overview

Palliative Stereotactic Radiation for 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.

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.

Pancreatic Cancer
Periampullary Adenocarcinoma

RADIATION: Stereotactic Body Radiation Therapy (SBRT)

J1273
NA_00070233 (OTHER Identifier) (OTHER: JHMIRB)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-08-08	Results First Submitted 2024-08-14	Last Update Submitted that met QC Criteria 2025-07-02
First Submitted that Met QC Criteria 2013-01-30	Results First Submitted that Met QC Criteria 2024-10-08	Last Update Posted (ACTUAL) 2025-07-20
First Posted (ACTUAL) 2013-02-01	Results First Posted 2024-10-10	Last Verified 2025-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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.

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.

Primary Outcome Measures	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	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)
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
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
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Amol Narang, M.D., Johns Hopkins University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record