Pancreatic CancerPhase 2NCT01781728
Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma
A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT) in people with Pancreatic Cancer and Periampullary Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Cancer, Periampullary Adenocarcinoma
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2013to 1 Jun 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatic Cancer, Periampullary Adenocarcinoma
- Being tested
- Stereotactic Body Radiation Therapy (SBRT)
- Keywords
- recurrent, unresectable, residual, stereotactic body radiation therapy (SBRT), palliative management
- Medical subject headings
- Pancreatic Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Stereotactic Body Radiation Therapy (SBRT) which included 5 consecutive fractions of 25 to 33 Gy, following 3 months of multiagent chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Locally advanced pancreatic cancer or locally recurrent pancreatic ductal adenocarcinoma | Experimental | Patients with pathologically confirmed, locally advanced pancreatic ductal adenocarcinoma (LAPC), unresectable at diagnosis, or local recurrence pancreatic ductal adenocarcinoma (PDAC) after prior surgical resection. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-treatment to date of first progression or date of death, whichever comes first assessed up to 36 months
Secondary outcomes (9)
Acute Gastrointestinal Toxicity
Any acute gastrointestinal (GI) toxicities grade 3 or greater.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3, 6, and 12 months after treatment
Linac Based SBRT Standardization
To develop and standardize Linac based SBRT delivery and dosimetric parameters
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study start1 Jan 2013
- Primary completion1 Mar 2021
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomized, controlled Phase 2 trial
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amol Narang, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781728
- Sponsor's protocol ID
- J1273
- Other IDs
- NA_00070233
- Status last verified
- Jul 2025
- First submitted
- 8 Aug 2012
- Last updated
- 20 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate Stereotactic Body Radiation Therapy For Palliative Management of Unresectable Recurrent or Residual Pancreatic or Periampullary Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01781728
- Acronym / sponsor ID
- J1273
- Conditions
- Pancreatic Cancer, Periampullary Adenocarcinoma
- Keywords
- recurrent, unresectable, residual, stereotactic body radiation therapy (SBRT), palliative management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 1 Feb 2013 (estimated)
- Results
- Posted 10 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized, controlled Phase 2 trial
| Arm | Type | Receives |
|---|---|---|
| Locally advanced pancreatic cancer or locally recurrent pancreatic ductal adenocarcinoma | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT)Patients with pathologically confirmed, locally advanced pancreatic ductal adenocarcinoma (LAPC), unresectable at diagnosis, or local recurrence pancreatic ductal adenocarcinoma (PDAC) after prior surgical resection. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Locally advanced pancreatic cancer or locally recurrent pancreatic ductal adenocarcinoma |
Primary outcome
Late Gastrointestinal Toxicities
Time frame: 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.
9 secondary outcomes
Acute Gastrointestinal Toxicity
Time frame: within 3 months of treatment
Local Progression Free Survival From SBRT
Time frame: 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
Time frame: 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)
Time frame: Baseline (Pre-SBRT) and at 3 months (Post-SBRT)
Linear Accelerator (Linac) Based SBRT Pain Control
Time frame: 3, 6, and 12 months after treatment
Linac Based SBRT Standardization
Time frame: 3, 6, and 12 months after treatment
FDG-PET Use for Planning and Estimation of Survival
Time frame: 3, 6, and 12 months after treatment and then annually thereafter
Toxicity for Patients With Chemotherapy, Surgery (Resection) and Radiation for Tumor Assessments
Time frame: Up to 36 months
Toxicity for Patients With Chemotherapy and Radiation (no Resection)
Time frame: Up to 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amol Narang, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT) in people with Pancreatic Cancer and Periampullary Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late Gastrointestinal Toxicities (time frame: 3 months post-treatment to date of first progression or date of death, whichever comes first assessed up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.