Pancreatic CancerNCT03704662
Preoperative Fractionated Radiation Therapy Versus Stereotactic Body Radiation Therapy for Resectable or Borderline Resectable, or Locally Advanced Type A Pancreatic Adenocarcinoma
A study testing Stereotactic Body Radiation Therapy and Preoperative Fractionated Radiation Therapy and Chemotherapy in people with Pancreatic Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Patients are randomized into two arms. Arm A patients will receive Stereotactic Body Radiation Therapy (SBRT) and Arm B patients with receive conventional concurrent chemotherapy and radiation therapy. 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 Body Radiation Therapy and Preoperative Fractionated Radiation Therapy and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2018to 1 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Pathologically confirmed (histologic or cytological), resectable, borderline resectable, or locally advanced type A adenocarcinoma of the pancreas; patients must have resectable, borderline resectable, or locally advanced type A disease, based on institutional standardized criteria and tumor board review.
- Patients with and without regional adenopathy are eligible.
- Patients are eligible with either no evidence of distant metastatic disease, or "equivocal" evidence of distant metastatic disease, as judged by multidisciplinary review. This "equivocal" definition can include small lung or liver lesions that are not able to be radiographically characterized otherwise. Any biopsy-proven metastatic disease will make the patient ineligible for study participation.
- History/physical examination, including collection of weight and vital signs, within 45 days prior to start of treatment.
- Diagnostic abdominal/pelvic CT with IV contrast or abdominopelvic MRI scan with perfusion and diffusion-weighted sequences within 45 days prior to study entry.
- Chest CT scan or X-ray within 30 days prior to study entry.
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- Radiation treatment planning abdominal CT. A recommended abdominal MRI will be done as a simulation (SIM) with interpretation. The CT SIM will not be done with interpretation. Positron emission tomography (PET) scan and MRI are both optional but encouraged. Ability to undergo abdominal MR scans for staging and radiation planning and follow-up is optional but encouraged.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 14 days of randomization.
- Age ≥ 18.
- Heme Onc (Chem 24) and cancer antigen (CA) 19-9/carcinoembryonic antigen (CEA) within 45 days prior to treatment, as follows:
- Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
- Platelets ≥100,000 cells/mm3 (see section 4)
- Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 4 x upper limit of normal
- Total bilirubin < 1.5 x upper normal mg/dL
- Alkaline phosphatase < 4 x upper limit of normal
- Not on hemodialysis.
- Negative serum pregnancy test (if applicable).
- Ability to swallow oral medications.
- Patients must have had at least one cycle of systemic chemotherapy without evidence of distant progression.
- Patient must provide study-specific informed consent prior to study entry.
- Women of childbearing potential and male participants who are sexually active must practice adequate contraception.
Who cannot join
- Distant metastatic disease.
- Prior invasive malignancy (except nonmelanomatous skin cancer), unless disease free for a minimum of three years (for example, carcinoma in situ of the breast, oral cavity or cervix are all permissible).
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- Any major surgery within 28 days prior to study entry (for example, insertion of a vascular access device or biliary stent, exploratory laparotomy and/or laparoscopy are not considered major surgery; biliary or gastric bypass is considered major surgery).
- Severe, active comorbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last six months.
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- Transmural myocardial infarction within three months prior to study entry.
- 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 before registration.
- Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function.
- Any unresolved bowel or bile duct obstruction.
- Major resection of the stomach or small bowel that could affect the absorption of capecitabine.
- Acquired immune deficiency syndrome (AIDS), based upon current Center for Disease Control (CDC) definition. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because patients receiving antiretroviral therapy may experience possible pharmacokinetic interactions with capecitabine.
- Absence of any significant medical comorbidity which would preclude the consideration of major pancreatic surgery.
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during the course of the study and for women three months after study therapy is completed and for men six months after study therapy is completed. This exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- Women who are lactating at the time of registration and who plan to be lactating through three months after study therapy is completed.
- Prior allergic reaction to capecitabine or gemcitabine.
- Participation in another interventional clinical treatment trial while on study (observational trials are permitted).
- Patients taking nonprotocol-specified chemotherapy agents or immune modulating agents for other medical conditions are not permitted to participate in this trial. Any medication questions should be reviewed by the PI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: A Randomized, Phase II Clinical Trial of Preoperative Fractionated Radiation Therapy Versus Stereotactic Body Radiation Therapy for Resectable or Borderline Resectable, or Locally Advanced Type A Pancreatic Adenocarcinoma
Patients are randomized into two arms. Arm A patients will receive Stereotactic Body Radiation Therapy (SBRT) and Arm B patients with receive conventional concurrent chemotherapy and radiation therapy.
Read the detailed description
RATIONALE: There are limited studies comparing novel radiation treatments with stereotactic body radiation therapy (SBRT) in pancreatic adenocarcinoma to conventional fractionation. Much of the existing literature indicates this technique is safe and convenient for patients, as compared with conventionally fractionated concurrent chemo-radiation therapy. However, there has been no direct comparison of these two treatment modalities when given in the preoperative setting. It also remains uncertain if SBRT results in similar nodal downstaging to preoperative, conventionally fractionated chemo-RT.
STUDY DESIGN: This study is a prospective, open-label, randomized, parallel, two-arm, phase II clinical trial. Patients meeting the eligibility criteria will be randomized after a minimum of one cycle of induction chemotherapy. These patients will be required to have no biopsy-proven distant disease on repeat staging studies before randomization. Patients who have radiologically equivocal evidence of distant metastatic disease (small lung nodules, or liver lesions that cannot be definitively characterized, etc.) are also eligible for enrollment. Patients with biopsy-proven metastatic disease are not eligible. The total number of patients planned for accrual is approximately 102 patients (51 patients per arm), with 14 additional patients enrolled to account for a roughly 15% drop out rate.
- Conditions
- Pancreatic Cancer
- Being tested
- Stereotactic Body Radiation Therapy, Preoperative Fractionated Radiation Therapy and Chemotherapy
- Keywords
- resectable pancreatic adenocarcinoma, borderline resectable pancreatic adenocarcinoma, Stereotactic Body Radiation Therapy, Preoperative Fractionated Radiation Therapy
- 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 Body Radiation TherapyRadiation
Also called SBRT
Undergo SBRT
Preoperative Fractionated Radiation Therapy and ChemotherapyRadiation
Conventional concurrent chemotherapy and radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiation Therapy | Other | Patients undergo Stereotactic Body Radiation Therapy (25 to 35 Gy over five fractions) Receives: Radiation: Stereotactic Body Radiation Therapy |
| Preoperative Fractionated Radiation Therapy and Chemotherapy | Other | Concurrent chemotherapy with radiation treatment (50.4 Gy over 28 fractions). Receives: Radiation: Preoperative Fractionated Radiation Therapy and Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects who present with node-positive disease following surgical resection.
Subjects will undergo surgical resection within three to eight weeks following treatment.
Measured: 8 weeks postradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start22 Oct 2018
- Primary completion11 Mar 2026
- Study completion1 Jun 2031 (estimated)
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 Medical College of WisconsinThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Hall, Medical College of Wisconsin
- Investigators
- William Hall, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704662
- Sponsor's protocol ID
- PRO00033061
- Status last verified
- Jul 2026
- First submitted
- 10 Oct 2018
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase II Clinical Trial of Preoperative Fractionated Radiation Therapy Versus Stereotactic Body Radiation Therapy for Resectable or Borderline Resectable, or Locally Advanced Type A Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03704662
- Acronym / sponsor ID
- PRO00033061
- Conditions
- Pancreatic Cancer
- Keywords
- resectable pancreatic adenocarcinoma, borderline resectable pancreatic adenocarcinoma, Stereotactic Body Radiation Therapy, Preoperative Fractionated Radiation Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 15 Oct 2018 (actual)
- 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.
Patients are randomized into two arms. Arm A patients will receive Stereotactic Body Radiation Therapy (SBRT) and Arm B patients with receive conventional concurrent chemotherapy and radiation therapy.
Detailed description
RATIONALE: There are limited studies comparing novel radiation treatments with stereotactic body radiation therapy (SBRT) in pancreatic adenocarcinoma to conventional fractionation. Much of the existing literature indicates this technique is safe and convenient for patients, as compared with conventionally fractionated concurrent chemo-radiation therapy. However, there has been no direct comparison of these two treatment modalities when given in the preoperative setting. It also remains uncertain if SBRT results in similar nodal downstaging to preoperative, conventionally fractionated chemo-RT.
STUDY DESIGN: This study is a prospective, open-label, randomized, parallel, two-arm, phase II clinical trial. Patients meeting the eligibility criteria will be randomized after a minimum of one cycle of induction chemotherapy. These patients will be required to have no biopsy-proven distant disease on repeat staging studies before randomization. Patients who have radiologically equivocal evidence of distant metastatic disease (small lung nodules, or liver lesions that cannot be definitively characterized, etc.) are also eligible for enrollment. Patients with biopsy-proven metastatic disease are not eligible. The total number of patients planned for accrual is approximately 102 patients (51 patients per arm), with 14 additional patients enrolled to account for a roughly 15% drop out rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiation Therapy | Other | Radiation: Stereotactic Body Radiation TherapyPatients undergo Stereotactic Body Radiation Therapy (25 to 35 Gy over five fractions) |
| Preoperative Fractionated Radiation Therapy and Chemotherapy | Other | Radiation: Preoperative Fractionated Radiation Therapy and ChemotherapyConcurrent chemotherapy with radiation treatment (50.4 Gy over 28 fractions). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Pathologically confirmed (histologic or cytological), resectable, borderline resectable, or locally advanced type A adenocarcinoma of the pancreas; patients must have resectable, borderline resectable, or locally advanced type A disease, based on institutional standardized criteria and tumor board review.
- Patients with and without regional adenopathy are eligible.
- Patients are eligible with either no evidence of distant metastatic disease, or "equivocal" evidence of distant metastatic disease, as judged by multidisciplinary review. This "equivocal" definition can include small lung or liver lesions that are not able to be radiographically characterized otherwise. Any biopsy-proven metastatic disease will make the patient ineligible for study participation.
- History/physical examination, including collection of weight and vital signs, within 45 days prior to start of treatment.
- Diagnostic abdominal/pelvic CT with IV contrast or abdominopelvic MRI scan with perfusion and diffusion-weighted sequences within 45 days prior to study entry.
Key exclusion criteria (19 listed)
- Distant metastatic disease.
- Prior invasive malignancy (except nonmelanomatous skin cancer), unless disease free for a minimum of three years (for example, carcinoma in situ of the breast, oral cavity or cervix are all permissible).
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- Any major surgery within 28 days prior to study entry (for example, insertion of a vascular access device or biliary stent, exploratory laparotomy and/or laparoscopy are not considered major surgery; biliary or gastric bypass is considered major surgery).
- 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 |
|---|---|---|
| Stereotactic Body Radiation TherapyAlso: SBRTUndergo SBRT | Radiation | Stereotactic Body Radiation Therapy |
| Preoperative Fractionated Radiation Therapy and ChemotherapyConventional concurrent chemotherapy and radiation therapy. | Radiation | Preoperative Fractionated Radiation Therapy and Chemotherapy |
Primary outcome
The number of subjects who present with node-positive disease following surgical resection.
Time frame: 8 weeks postradiation
Subjects will undergo surgical resection within three to eight weeks following treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- 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.
William Hall, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy and Preoperative Fractionated Radiation Therapy and Chemotherapy in people with Pancreatic Cancer, run by Medical College of Wisconsin 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 22 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
The number of subjects who present with node-positive disease following surgical resection. (time frame: 8 weeks postradiation). 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 2026.