Pancreatic AdenocarcinomaPhase 2NCT03073785
Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer
A Phase 2 study testing Capecitabine, Fluorouracil and Laboratory Biomarker Analysis in people with Pancreatic Adenocarcinoma and Recurrent Pancreatic Carcinoma, run by University of Nebraska at 1 site in United States.
Trial summary
Pancreatic cancer, most commonly adenocarcinoma, is the fourth leading cause of cancer death in the United States. The mainstay of management centers on surgical resection (if resectable) and although low (15% to 20%), resectability rates are associated with dismal survival. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma, Recurrent Pancreatic Carcinoma, Stage I Pancreatic Cancer AJCC v6 and v7
- What is being tested?
- Capecitabine, Fluorouracil and Laboratory Biomarker Analysis
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2017to Dec 2027
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed pancreatic adenocarcinoma, either initially diagnosed or recurrent locally advanced disease. The maximum dimension of the treatment target must be =<10 cm. Locally advanced disease defined as: T 1-2N+MO or T3-4 NxMo, or borderline resectable and unresectable adenocarcinoma without distant metastatic disease or resectable T3-4 NxMo disease or M1 with controlled distant disease
- Inoperable conditions with resectable disease (T1-2NoMo)
- Karnofsky performance status of 60% or better. Received recent chemotherapy for pancreatic cancer or completed chemotherapy > 5 years ago for malignancies other than pancreatic cancer with no evidence of the second malignancy at study entry
- Radiation therapy completed > 5 years ago for malignancies other than pancreatic cancer and whose radiation therapy field is not overlapping with the 20% isodose line of current radiation field and no evidence of the second malignancy at study entry
- All malignant disease must be able to be encompassed within a single irradiation field
- Absolute neutrophil count (ANC) greater than or equal to 1500/uL
Show all 11Show fewer
- Radiographically assessable disease
- Platelet count greater than or equal to 100,000/uL
- Serum creatinine less than or equal to 2.0 mg/dL and total bilirubin less than or equal to 2.0 mg/dL in the absence of biliary obstruction. If biliary obstruction is present, biliary decompression will be required, either endoscopic placement of a biliary stent or percutaneous transhepatic. Once biliary drainage has been established, institution of protocol therapy may proceed when the total bilirubin falls to 4.0 mg/dL or lower
- Calculated creatinine clearance of >= 35.
- Awareness of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
Who cannot join
- Known allergy to Zometa or to anti-emetics appropriate in conjunction with protocol-directed therapy
- Uncontrolled inter-current illness that might jeopardize the ability of the subject to receive the protocol therapy with reasonable safety. This may include, but not limited to, ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure, unstable angina pectoris, or serious, uncontrolled cardiac arrhythmia
- Pregnant and nursing women
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, adequately treated non-invasive carcinomas, or be disease-free for at least 5 years from other cancers
- Active duodenal ulcer or bleeding or history of a gastrointestinal fistula or perforation or other significant bowel problems (severe nausea, vomiting, inflammatory bowel disease and significant bowel resection)
- Known human immunodeficiency virus (HIV) infection, or hepatic insufficiency
- Not currently receiving or have received Zometa within 3 weeks prior to study treatment with Zometa
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: A Randomized Phase II Study of the Efficacy and Safety of Hypofractionated Stereotactic Radiotherapy and 5FU or Capecitabine With and Without Zometa in Patients With Locally Advanced Pancreatic Adenocarcinoma
Pancreatic cancer, most commonly adenocarcinoma, is the fourth leading cause of cancer death in the United States. The mainstay of management centers on surgical resection (if resectable) and although low (15% to 20%), resectability rates are associated with dismal survival. An estimated 80% to 85% of the patients recur after surgical resection, leading to a median survival of 20 to 24 months and potentially even less depending on lymph nodal involvement or positive margins. The rationale for utilizing neoadjuvant therapy, commonly fluoropyrimidine-based or gemcitabine based chemotherapy or Chemoradiotherapy (CRT), involves possibly down staging borderline resectable and unresectable patients, potentially making them resectable candidates.
This randomized phase II trial will study how well hypofractionated stereotactic body radiation therapy (SBRT) and fluorouracil or capecitabine with or without zoledronic acid work in treating participants with pancreatic cancer that has spread to nearby tissue or lymph nodes. Hypofractionated stereotactic body radiation therapy is a specialized radiation therapy that sends higher doses of x-rays over a shorter period of time directly to the tumor using smaller doses over several days which may cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Zoledronic acid is used in cancer patients to reduce cancer symptoms and may make tumor cells more sensitive to radiation. Giving hypofractionated stereotactic body radiation therapy and fluorouracil or capecitabine with or without zoledronic acid may work better in treating pancreatic cancer.
Read the detailed description
Pancreatic cancer, most commonly adenocarcinoma, is the fourth leading cause of cancer death in the United States. The mainstay of management centers on surgical resection (if resectable) and although low (15% to 20%), resectability rates are associated with dismal survival. An estimated 80% to 85% of the patients recur after surgical resection, leading to a median survival of 20 to 24 months and potentially even less depending on lymph nodal involvement or positive margins. The rationale for utilizing neoadjuvant therapy, commonly fluoropyrimidine-based or gemcitabine based chemotherapy or Chemoradiotherapy (CRT), involves possibly down staging borderline resectable and unresectable patients, potentially making them resectable candidates.
This randomized phase II trial will study how well hypofractionated stereotactic body radiation therapy (SBRT) and fluorouracil or capecitabine with or without zoledronic acid work in treating participants with pancreatic cancer that has spread to nearby tissue or lymph nodes. Hypofractionated stereotactic body radiation therapy is a specialized radiation therapy that sends higher doses of x-rays over a shorter period of time directly to the tumor using smaller doses over several days which may cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Zoledronic acid is used in cancer patients to reduce cancer symptoms and may make tumor cells more sensitive to radiation. Giving hypofractionated stereotactic body radiation therapy and fluorouracil or capecitabine with or without zoledronic acid may work better in treating pancreatic cancer.
The primary study objective is to evaluate the efficacy of hypofractionated radiation therapy concurrently with zoledronic acid (Zometa) and fluorouracil or capecitabine. Other study objectives include examining the toxicity of Zometa when used concurrently with hypofractionated radiation therapy, evaluating local failure-free survival and overall survival, determining surgical resection and tumor response rates, measuring Zometa pharmacokinetics, evaluating tumor and organ motion and determining the effect those on the dosimetry, local control and survival. Post-treatment follow-up is for 30 days, then every 3 months for the first year, every 4 months for the second year, and every 6 months thereafter.
- Conditions
- Pancreatic Adenocarcinoma, Recurrent Pancreatic Carcinoma, Stage I Pancreatic Cancer AJCC v6 and v7, Stage IA Pancreatic Cancer AJCC v6 and v7, Stage IB Pancreatic Cancer AJCC v6 and v7, Stage II Pancreatic Cancer AJCC v6 and v7
- Being tested
- Capecitabine, Fluorouracil, Laboratory Biomarker Analysis, Pharmacological Study, Stereotactic Body 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.
CapecitabineDrug
Also called Ro 09-1978/000, Xeloda
Given by mouth (PO)
FluorouracilDrug
Also called 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FU
Given Intravenously (IV)
Laboratory Biomarker AnalysisOther
Correlative studies
Correlative studies
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo hypofractionated stereotactic radiotherapy
Zoledronic AcidDrug
Also called [1-Hydroxy-2-(1H-imidazol-1-yl)ethylidene]bisphosphonic Acid, CGP 42446, CGP42446A, NDC-Zoledronate
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm A (chemotherapy, radiation therapy) | Active comparator | Participants undergo hypofractionated stereotactic body radiation therapy in 5 fractions on days 1-5. Participants receive fluorouracil IV over 24 hours on day 1 weekly for 4 weeks or capecitabine by mouth every 12 hours starting the evening before day 1 of radiation therapy for 4 weeks as per standard of care. Participants then undergo surgery 6-8 weeks after completion of radiation therapy. Receives: Drug: Capecitabine; Drug: Fluorouracil; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Radiation: Stereotactic Body Radiation Therapy |
| Arm B (zoledronic acid, chemotherapy, radiation therapy) | Experimental | Participants receive zoledronic acid IV over a minimum of 15 minutes 1 week prior to radiation therapy. Participants undergo hypofractionated stereotactic body radiation therapy and receive treatment with fluorouracil IV or capecitabine by mouth as in Arm A. Participants then undergo surgery 6-8 weeks after completion of radiation therapy. Receives: Drug: Capecitabine; Drug: Fluorouracil; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Radiation: Stereotactic Body Radiation Therapy; Drug: Zoledronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control With and Without Zometa at Four Months in Follow-up
Local control will be assessed using three-dimensional (3D) computed tomography (CT). The primary tumor will be contoured using Varian planning software, and tumor volume will be measured at baseline and at 4 months post-treatment. Local control is defined as absence of disease progression, with progression defined as a ≥25% increase in tumor volume. Tumor response will also be assessed using RECIST-based criteria (≥20% increase in tumor diameter) as a supportive analysis.
Measured: At 4 months in follow-up
Local Control With and Without Zometa at Eight Months in Follow-up
Local control will be assessed using three-dimensional (3D) computed tomography (CT). The primary tumor will be contoured using Varian planning software, and tumor volume will be measured at baseline and at 8 months post-treatment. Local control is defined as absence of disease progression, with progression defined as a ≥25% increase in tumor volume. Tumor response will also be assessed using RECIST-based criteria (≥20% increase in tumor diameter) as a supportive analysis.
Measured: At 8 months in follow-up
Local Control With and Without Zometa at Twelve Months in Follow-up
Local control will be assessed using three-dimensional (3D) computed tomography (CT). The primary tumor will be contoured using Varian planning software, and tumor volume will be measured at baseline and at 12 months post-treatment. Local control is defined as absence of disease progression, with progression defined as a ≥25% increase in tumor volume. Tumor response will also be assessed using RECIST-based criteria (≥20% increase in tumor diameter) as a supportive analysis.
Measured: At 12 months in follow-up
Secondary outcomes (6)
Grade 3 and Above Adverse Events With and Without Zoledronic Acid
Grade 3 and above adverse events (AE) will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Measured: Up to 30 days after treatment
Failure-free Survival With and Without Zometa
Time to any failure (disease progression or recurrence determined by imaging, or death) will be analyzed using Kaplan-Meier method between participants receiving Zometa and those who don't.
Measured: From date of administration of study drug to the date of any failure, assessed up to 5 years
Overall Survival With and Without Zometa
Time to death will be analyzed using Kaplan-Meier method between participants receiving Zometa and those who don't.
Measured: From date of administration of study drug to the date of death, assessed up to 5 years
Surgically Complete Resection Rate With and Without Zometa
The number and proportion of participants undergoing complete resection (negative margin) will be determined between participants receiving Zometa and those who don't.
Measured: Immediately after surgery
Pathologic Response After Resection With and Without Zometa
The pathologic response will be scored from 0-9 by a pathologist, 0 is no response and 9 is complete response between participants receiving Zometa and those who don't.
Measured: Immediately after surgery
All-Cause Mortality
All anticipated and unanticipated deaths due to any cause
Measured: From date of administration of study drug to the date of death, assessed up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start23 Mar 2017
- Primary completion12 Dec 2023
- Study completionDec 2027 (estimated)
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 AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Chi Lin, MD, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073785
- Sponsor's protocol ID
- 0552-16-FB
- Other IDs
- NCI-2016-01360, P30CA036727
- Status last verified
- Sep 2026
- First submitted
- 28 Feb 2017
- Last updated
- 4 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of the Efficacy and Safety of Hypofractionated Stereotactic Radiotherapy and 5FU or Capecitabine With and Without Zometa in Patients With Locally Advanced Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03073785
- Acronym / sponsor ID
- 0552-16-FB
- Conditions
- Pancreatic Adenocarcinoma, Recurrent Pancreatic Carcinoma, Stage I Pancreatic Cancer AJCC v6 and v7, Stage IA Pancreatic Cancer AJCC v6 and v7, Stage IB Pancreatic Cancer AJCC v6 and v7, Stage II Pancreatic Cancer AJCC v6 and v7
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Mar 2017 (actual)
- Results
- Posted 4 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pancreatic cancer, most commonly adenocarcinoma, is the fourth leading cause of cancer death in the United States. The mainstay of management centers on surgical resection (if resectable) and although low (15% to 20%), resectability rates are associated with dismal survival. An estimated 80% to 85% of the patients recur after surgical resection, leading to a median survival of 20 to 24 months and potentially even less depending on lymph nodal involvement or positive margins. The rationale for utilizing neoadjuvant therapy, commonly fluoropyrimidine-based or gemcitabine based chemotherapy or Chemoradiotherapy (CRT), involves possibly down staging borderline resectable and unresectable patients, potentially making them resectable candidates.
This randomized phase II trial will study how well hypofractionated stereotactic body radiation therapy (SBRT) and fluorouracil or capecitabine with or without zoledronic acid work in treating participants with pancreatic cancer that has spread to nearby tissue or lymph nodes. Hypofractionated stereotactic body radiation therapy is a specialized radiation therapy that sends higher doses of x-rays over a shorter period of time directly to the tumor using smaller doses over several days which may cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Zoledronic acid is used in cancer patients to reduce cancer symptoms and may make tumor cells more sensitive to radiation. Giving hypofractionated stereotactic body radiation therapy and fluorouracil or capecitabine with or without zoledronic acid may work better in treating pancreatic cancer.
Detailed description
Pancreatic cancer, most commonly adenocarcinoma, is the fourth leading cause of cancer death in the United States. The mainstay of management centers on surgical resection (if resectable) and although low (15% to 20%), resectability rates are associated with dismal survival. An estimated 80% to 85% of the patients recur after surgical resection, leading to a median survival of 20 to 24 months and potentially even less depending on lymph nodal involvement or positive margins. The rationale for utilizing neoadjuvant therapy, commonly fluoropyrimidine-based or gemcitabine based chemotherapy or Chemoradiotherapy (CRT), involves possibly down staging borderline resectable and unresectable patients, potentially making them resectable candidates.
This randomized phase II trial will study how well hypofractionated stereotactic body radiation therapy (SBRT) and fluorouracil or capecitabine with or without zoledronic acid work in treating participants with pancreatic cancer that has spread to nearby tissue or lymph nodes. Hypofractionated stereotactic body radiation therapy is a specialized radiation therapy that sends higher doses of x-rays over a shorter period of time directly to the tumor using smaller doses over several days which may cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Zoledronic acid is used in cancer patients to reduce cancer symptoms and may make tumor cells more sensitive to radiation. Giving hypofractionated stereotactic body radiation therapy and fluorouracil or capecitabine with or without zoledronic acid may work better in treating pancreatic cancer.
The primary study objective is to evaluate the efficacy of hypofractionated radiation therapy concurrently with zoledronic acid (Zometa) and fluorouracil or capecitabine. Other study objectives include examining the toxicity of Zometa when used concurrently with hypofractionated radiation therapy, evaluating local failure-free survival and overall survival, determining surgical resection and tumor response rates, measuring Zometa pharmacokinetics, evaluating tumor and organ motion and determining the effect those on the dosimetry, local control and survival. Post-treatment follow-up is for 30 days, then every 3 months for the first year, every 4 months for the second year, and every 6 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (chemotherapy, radiation therapy) | Active comparator | Drug: Capecitabine, Drug: Fluorouracil, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Radiation: Stereotactic Body Radiation TherapyParticipants undergo hypofractionated stereotactic body radiation therapy in 5 fractions on days 1-5. Participants receive fluorouracil IV over 24 hours on day 1 weekly for 4 weeks or capecitabine by mouth every 12 hours starting the evening before day 1 of radiation therapy for 4 weeks as per standard of care. Participants then undergo surgery 6-8 weeks after completion of radiation therapy. |
| Arm B (zoledronic acid, chemotherapy, radiation therapy) | Experimental | Drug: Capecitabine, Drug: Fluorouracil, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Radiation: Stereotactic Body Radiation Therapy, Drug: Zoledronic AcidParticipants receive zoledronic acid IV over a minimum of 15 minutes 1 week prior to radiation therapy. Participants undergo hypofractionated stereotactic body radiation therapy and receive treatment with fluorouracil IV or capecitabine by mouth as in Arm A. Participants then undergo surgery 6-8 weeks after completion of radiation therapy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pathologically confirmed pancreatic adenocarcinoma, either initially diagnosed or recurrent locally advanced disease. The maximum dimension of the treatment target must be =<10 cm. Locally advanced disease defined as: T 1-2N+MO or T3-4 NxMo, or borderline resectable and unresectable adenocarcinoma without distant metastatic disease or resectable T3-4 NxMo disease or M1 with controlled distant disease
- Inoperable conditions with resectable disease (T1-2NoMo)
- Karnofsky performance status of 60% or better. Received recent chemotherapy for pancreatic cancer or completed chemotherapy > 5 years ago for malignancies other than pancreatic cancer with no evidence of the second malignancy at study entry
- Radiation therapy completed > 5 years ago for malignancies other than pancreatic cancer and whose radiation therapy field is not overlapping with the 20% isodose line of current radiation field and no evidence of the second malignancy at study entry
- All malignant disease must be able to be encompassed within a single irradiation field
Key exclusion criteria (7 listed)
- Known allergy to Zometa or to anti-emetics appropriate in conjunction with protocol-directed therapy
- Uncontrolled inter-current illness that might jeopardize the ability of the subject to receive the protocol therapy with reasonable safety. This may include, but not limited to, ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure, unstable angina pectoris, or serious, uncontrolled cardiac arrhythmia
- Pregnant and nursing women
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, adequately treated non-invasive carcinomas, or be disease-free for at least 5 years from other cancers
- Active duodenal ulcer or bleeding or history of a gastrointestinal fistula or perforation or other significant bowel problems (severe nausea, vomiting, inflammatory bowel disease and significant bowel resection)
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 |
|---|---|---|
| CapecitabineAlso: Ro 09-1978/000, XelodaGiven by mouth (PO) | Drug | Arm A (chemotherapy, radiation therapy), Arm B (zoledronic acid, chemotherapy, radiation therapy) |
| FluorouracilAlso: 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FUGiven Intravenously (IV) | Drug | Arm A (chemotherapy, radiation therapy), Arm B (zoledronic acid, chemotherapy, radiation therapy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm A (chemotherapy, radiation therapy), Arm B (zoledronic acid, chemotherapy, radiation therapy) |
| Pharmacological StudyCorrelative studies | Other | Arm A (chemotherapy, radiation therapy), Arm B (zoledronic acid, chemotherapy, radiation therapy) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo hypofractionated stereotactic radiotherapy | Radiation | Arm A (chemotherapy, radiation therapy), Arm B (zoledronic acid, chemotherapy, radiation therapy) |
| Zoledronic AcidAlso: [1-Hydroxy-2-(1H-imidazol-1-yl)ethylidene]bisphosphonic Acid, CGP 42446, CGP42446A, NDC-ZoledronateGiven IV | Drug | Arm B (zoledronic acid, chemotherapy, radiation therapy) |
Primary outcome
Local Control With and Without Zometa at Four Months in Follow-up
Time frame: At 4 months in follow-up
Local control will be assessed using three-dimensional (3D) computed tomography (CT). The primary tumor will be contoured using Varian planning software, and tumor volume will be measured at baseline and at 4 months post-treatment. Local control is defined as absence of disease progression, with progression defined as a ≥25% increase in tumor volume. Tumor response will also be assessed using RECIST-based criteria (≥20% increase in tumor diameter) as a supportive analysis.
Local Control With and Without Zometa at Eight Months in Follow-up
Time frame: At 8 months in follow-up
Local control will be assessed using three-dimensional (3D) computed tomography (CT). The primary tumor will be contoured using Varian planning software, and tumor volume will be measured at baseline and at 8 months post-treatment. Local control is defined as absence of disease progression, with progression defined as a ≥25% increase in tumor volume. Tumor response will also be assessed using RECIST-based criteria (≥20% increase in tumor diameter) as a supportive analysis.
Local Control With and Without Zometa at Twelve Months in Follow-up
Time frame: At 12 months in follow-up
Local control will be assessed using three-dimensional (3D) computed tomography (CT). The primary tumor will be contoured using Varian planning software, and tumor volume will be measured at baseline and at 12 months post-treatment. Local control is defined as absence of disease progression, with progression defined as a ≥25% increase in tumor volume. Tumor response will also be assessed using RECIST-based criteria (≥20% increase in tumor diameter) as a supportive analysis.
6 secondary outcomes
Grade 3 and Above Adverse Events With and Without Zoledronic Acid
Time frame: Up to 30 days after treatment
Failure-free Survival With and Without Zometa
Time frame: From date of administration of study drug to the date of any failure, assessed up to 5 years
Overall Survival With and Without Zometa
Time frame: From date of administration of study drug to the date of death, assessed up to 5 years
Surgically Complete Resection Rate With and Without Zometa
Time frame: Immediately after surgery
Pathologic Response After Resection With and Without Zometa
Time frame: Immediately after surgery
All-Cause Mortality
Time frame: From date of administration of study drug to the date of death, assessed up to 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- 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.
Chi Lin, MD, PhD principal investigator
University of Nebraska
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 Capecitabine, Fluorouracil and Laboratory Biomarker Analysis in people with Pancreatic Adenocarcinoma and Recurrent Pancreatic Carcinoma, run by University of Nebraska 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 11 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 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.
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 4 Nov 2026). 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?
Local Control With and Without Zometa at Four Months in Follow-up (time frame: At 4 months in follow-up). The study lists 3 primary outcomes in all. 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 4 Nov 2026.