Pancreatic CancerNCT02347618
Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer
A study testing Preoperative SBRT in people with Pancreatic Cancer and Adenocarcinoma, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a short-course of stereotactic body radiotherapy (SBRT) prior to surgical resection of pancreatic adenocarcinoma is feasible and well-tolerated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Adenocarcinoma
- What is being tested?
- Preoperative SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 13 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient with pathologically proven diagnosis of adenocarcinoma of the head of the pancreas
- CT w/ contrast using the pancreas protocol or MRI of the abdomen with contrast within 6 weeks prior to registration
- CT chest or PET/CT within 6 weeks prior to registration
- Clinically determined to be resectable based on NCCN Criteria:
- No radiographic evidence of superior mesenteric vein or portal vein distortion
- No evidence of distant metastasis
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- Clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery
- No enlarged lymph nodes per CT criteria or PET avid lymph nodes
- No lymphadenopathy outside the surgical field (i.e. celiac or para-aortic adenopathy)
- Adequate cardiopulmonary reserves to tolerate surgery
- Karnofsky performance status > 70
- Age >18
- Adequate bone marrow function defined as follows:
- Absolute neutrophil count (ANC) > 1800 cells/mm3
- Platelets ≥ 100,000 cells/mm3
- Hemoglobin > 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > 8 g/dl is acceptable.)
- Pregnancy test must be negative for women of childbearing potential within 7 days prior to study entry
- Patient must sign study specific informed consent prior to study entry
Who cannot join
- Prior surgical resection of any pancreatic malignancy
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
- Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Severe, active comorbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months
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- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration.
- Severe, uncorrectable hepatic insufficiency and/or coagulation defects due to liver failure
- Any evidence of distant metastases (M1)
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
The purpose of this study is to determine whether a short-course of stereotactic body radiotherapy (SBRT) prior to surgical resection of pancreatic adenocarcinoma is feasible and well-tolerated.
Read the detailed description
This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.
- Conditions
- Pancreatic Cancer, Adenocarcinoma
- Being tested
- Preoperative SBRT
- Medical subject headings
- Pancreatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative SBRTRadiation
This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative SBRT | Experimental | This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma. Receives: Radiation: Preoperative SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 2 or greater toxicity
Number of incidence of grade 2 or greater toxicity
Measured: 2 years
Secondary outcomes (4)
Number of Participants with no further growth of cancer at original site (Local control)
Count subjects with no further growth of cancer at original site.
Measured: 2 years
Count subjects with Recurrence of cancer in other body sites
Compare recurrence locations of treated patients relative to historical controls.
Measured: 2 years
Time to Progression of pancreatic cancer
Duration of progression free survival of treated patients
Measured: 4 years
Time to death
Measure duration of survival of treated patients.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startDec 2014
- Primary completion13 Apr 2022
- Study completion13 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Katz, University of Rochester
- Investigators
- Alan W Katz, MD MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347618
- Sponsor's protocol ID
- UGIP14107
- Status last verified
- Jul 2022
- First submitted
- 24 Dec 2014
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02347618
- Acronym / sponsor ID
- UGIP14107
- Conditions
- Pancreatic Cancer, Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- 13 Apr 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a short-course of stereotactic body radiotherapy (SBRT) prior to surgical resection of pancreatic adenocarcinoma is feasible and well-tolerated.
Detailed description
This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative SBRT | Experimental | Radiation: Preoperative SBRTThis will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patient with pathologically proven diagnosis of adenocarcinoma of the head of the pancreas
- CT w/ contrast using the pancreas protocol or MRI of the abdomen with contrast within 6 weeks prior to registration
- CT chest or PET/CT within 6 weeks prior to registration
- Clinically determined to be resectable based on NCCN Criteria:
- No radiographic evidence of superior mesenteric vein or portal vein distortion
Key exclusion criteria (12 listed)
- Prior surgical resection of any pancreatic malignancy
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
- Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Severe, active comorbidity, defined as follows:
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 |
|---|---|---|
| Preoperative SBRTThis will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma. | Radiation | Preoperative SBRT |
Primary outcome
Incidence of grade 2 or greater toxicity
Time frame: 2 years
Number of incidence of grade 2 or greater toxicity
4 secondary outcomes
Number of Participants with no further growth of cancer at original site (Local control)
Time frame: 2 years
Count subjects with Recurrence of cancer in other body sites
Time frame: 2 years
Time to Progression of pancreatic cancer
Time frame: 4 years
Time to death
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
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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.
Alan W Katz, MD MPH principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative SBRT in people with Pancreatic Cancer and Adenocarcinoma, run by University of Rochester 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 18 inclusion and 12 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 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of grade 2 or greater toxicity (time frame: 2 years). 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 2022.