Pancreatic CancerPhase 1/2NCT01342354
Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer
A Phase 1/2 study testing Stereotactic Radiation 10 Gy, Stereotactic Radiation 12.5 Gy and Stereotactic Radiation 15 Gy in people with Pancreatic Cancer, run by University of Chicago at 1 site in United States.
Trial summary
This purpose of this study is to determine the highest tolerated dose of Stereotactic Body Radiation Therapy (SBRT) and also to determine the appropriate dose for intact pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Stereotactic Radiation 10 Gy, Stereotactic Radiation 12.5 Gy and Stereotactic Radiation 15 Gy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2009to 1 Jun 2022
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed, unresected cancer of the pancreas or ampulla. The cancer may include any invasive histology (e.g. adenocarcinoma, neuroendocrine carcinoma).
- Patients must have measurable radiographic disease.Patients with previous complete resection are only eligible if there is measurable radiographic disease which is clearly felt to represent locally recurrent disease.
- Patients may receive any number of cycles of chemotherapy prior to treatment with SBRT, but not within 2 weeks of the first fraction of RT.
- Age > or = 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 (Karnofsky > or = 60%)
- Life expectancy of greater than 3 months.
- Patients must have normal organ and marrow function.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Concurrent investigational therapy delivered over the period of treatment or observation (28 days post-RT) for dose limiting toxicity.
- Prior radiation therapy to the abdominal area which would overlap with the proposed area of treatment.
- Pregnancy.
- Primary disease > 7.5 cm in largest diameter as measured by CT or MRI.
- Gross extension of tumor into the lumen of the duodenum.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Use of bevacizumab or vascular endothelial growth factor inhibitor chemotherapy within 3 months before RT or 6 months after RT.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Stereotactic Body Radiation Therapy in Patients With Unresected Carcinoma of the Pancreas or Ampulla
This purpose of this study is to determine the highest tolerated dose of Stereotactic Body Radiation Therapy (SBRT) and also to determine the appropriate dose for intact pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- Stereotactic Radiation 10 Gy, Stereotactic Radiation 12.5 Gy, Stereotactic Radiation 15 Gy
- Keywords
- Pancreatic Cancer, Stereotactic Radiation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Radiation 10 GyRadiation
10 Gy three times over 10 days
Stereotactic Radiation 12.5 GyRadiation
12.5 Gy three times over 10 days
Stereotactic Radiation 15 GyRadiation
15 Gy three times over 10 days
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Radiation: 10 Gy x3 | Experimental | Level 1 - SBRT 10Gy in three doses over ten days (total 30 Gy). Receives: Radiation: Stereotactic Radiation 10 Gy |
| Stereotactic Radiation: 12.5 Gy x3 | Experimental | Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy). Receives: Radiation: Stereotactic Radiation 12.5 Gy |
| Stereotactic Radiation: 15 Gy x3 | Experimental | Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy). Receives: Radiation: Stereotactic Radiation 15 Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (Phase 1)
Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation.
Measured: 28 days
Secondary outcomes (5)
The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity
Grade 3+ GI late toxicity
Measured: 12 months after treatment
Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale
Using the visual analog scale, patients rate pain from 1-10 with higher scores indicate greater pain intensity. Improvement in pain is defined as a yes/no response.
Measured: 12 months after treatment
Number of Patients Eligible for Surgery to Remove Tumor After Treatment
Measured: 12 months after treatment
Number of Patients With Local Disease Control
Number of patients with no disease progression as measured by tumor imaging, based on RECIST criteria
Measured: 12 months after treatment
Change From Baseline in Patient Reported Outcomes Using FACT-Hepatobiliary (FACT-Hep) Quality of Life Questionnaire.
The Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) is an instrument that assesses health-related quality of life in patients with hepatobiliary cancers. The FACT-Hep consists of the FACT-G, which assesses generic health-related quality of life and concerns, and a validated Hepatobiliary Subscale (HS), which assesses disease-specific issues. Responses are on a 5 point Likert-type scale; items are summed to generate scores, with higher scores indicating better QOL (possible range of total score = 0-180).
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study start14 Apr 2009
- Primary completionAug 2020
- Study completion1 Jun 2022
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 University of ChicagoThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stanley Liauw, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342354
- Sponsor's protocol ID
- 16866B
- Status last verified
- Jun 2025
- First submitted
- 15 Apr 2011
- Last updated
- 18 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Stereotactic Body Radiation Therapy in Patients With Unresected Carcinoma of the Pancreas or Ampulla
- ClinicalTrials.gov ID
- NCT01342354
- Acronym / sponsor ID
- 16866B
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Stereotactic Radiation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 14 Apr 2009 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 27 Apr 2011 (estimated)
- Results
- Posted 18 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to determine the highest tolerated dose of Stereotactic Body Radiation Therapy (SBRT) and also to determine the appropriate dose for intact pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Radiation: 10 Gy x3 | Experimental | Radiation: Stereotactic Radiation 10 GyLevel 1 - SBRT 10Gy in three doses over ten days (total 30 Gy). |
| Stereotactic Radiation: 12.5 Gy x3 | Experimental | Radiation: Stereotactic Radiation 12.5 GyLevel 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy). |
| Stereotactic Radiation: 15 Gy x3 | Experimental | Radiation: Stereotactic Radiation 15 GyLevel 3 - SBRT 15Gy in three doses over ten days (total 45 Gy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have histologically confirmed, unresected cancer of the pancreas or ampulla. The cancer may include any invasive histology (e.g. adenocarcinoma, neuroendocrine carcinoma).
- Patients must have measurable radiographic disease.Patients with previous complete resection are only eligible if there is measurable radiographic disease which is clearly felt to represent locally recurrent disease.
- Patients may receive any number of cycles of chemotherapy prior to treatment with SBRT, but not within 2 weeks of the first fraction of RT.
- Age > or = 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 (Karnofsky > or = 60%)
Key exclusion criteria (7 listed)
- Concurrent investigational therapy delivered over the period of treatment or observation (28 days post-RT) for dose limiting toxicity.
- Prior radiation therapy to the abdominal area which would overlap with the proposed area of treatment.
- Pregnancy.
- Primary disease > 7.5 cm in largest diameter as measured by CT or MRI.
- Gross extension of tumor into the lumen of the duodenum.
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 Radiation 10 Gy10 Gy three times over 10 days | Radiation | Stereotactic Radiation: 10 Gy x3 |
| Stereotactic Radiation 12.5 Gy12.5 Gy three times over 10 days | Radiation | Stereotactic Radiation: 12.5 Gy x3 |
| Stereotactic Radiation 15 Gy15 Gy three times over 10 days | Radiation | Stereotactic Radiation: 15 Gy x3 |
Primary outcome
Maximum Tolerated Dose (Phase 1)
Time frame: 28 days
Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation.
5 secondary outcomes
The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity
Time frame: 12 months after treatment
Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale
Time frame: 12 months after treatment
Number of Patients Eligible for Surgery to Remove Tumor After Treatment
Time frame: 12 months after treatment
Number of Patients With Local Disease Control
Time frame: 12 months after treatment
Change From Baseline in Patient Reported Outcomes Using FACT-Hepatobiliary (FACT-Hep) Quality of Life Questionnaire.
Time frame: 12 months after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Stanley Liauw, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stereotactic Radiation 10 Gy, Stereotactic Radiation 12.5 Gy and Stereotactic Radiation 15 Gy in people with Pancreatic Cancer, run by University of Chicago 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 8 inclusion and 7 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 18 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 18 Jul 2025). 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?
Maximum Tolerated Dose (Phase 1) (time frame: 28 days). 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 18 Jul 2025.