Trial · NCT03073785
Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer
NCT03073785, Phase 2, Active not recruiting, University of Nebraska
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer. Trials, record NCT03073785. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03073785
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer
- NCT number
- NCT03073785
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- University of Nebraska
- 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, Stage IIA Pancreatic Cancer AJCC v6 and v7, Stage IIB Pancreatic Cancer AJCC v6 and v7, Stage III Pancreatic Cancer AJCC v6 and v7, Stage IV Pancreatic Cancer AJCC v6 and v7
- Interventions
- Capecitabine, Fluorouracil, Laboratory Biomarker Analysis, Pharmacological Study, Stereotactic Body Radiation Therapy, Zoledronic Acid
- First posted
- 2017-03-08
- Last updated
- 2026-11-04
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Local Control With and Without Zometa at Four Months in Follow-up | 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. |
| Primary | Local Control With and Without Zometa at Eight Months in Follow-up | 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. |
| Primary | Local Control With and Without Zometa at Twelve Months in Follow-up | 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. |
| Secondary | Grade 3 and Above Adverse Events With and Without Zoledronic Acid | Up to 30 days after treatment | Grade 3 and above adverse events (AE) will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. |
| Secondary | Failure-free Survival With and Without Zometa | From date of administration of study drug to the date of any failure, assessed up to 5 years | 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. |
| Secondary | Overall Survival With and Without Zometa | From date of administration of study drug to the date of death, assessed up to 5 years | Time to death will be analyzed using Kaplan-Meier method between participants receiving Zometa and those who don't. |
| Secondary | Surgically Complete Resection Rate With and Without Zometa | Immediately after surgery | The number and proportion of participants undergoing complete resection (negative margin) will be determined between participants receiving Zometa and those who don't. |
| Secondary | Pathologic Response After Resection With and Without Zometa | Immediately after surgery | 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. |
| Secondary | All-Cause Mortality | From date of administration of study drug to the date of death, assessed up to 10 years | All anticipated and unanticipated deaths due to any cause |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA036727 | Buffett Cancer Center Support Grant | SWEASY, JOANN B. | UNIVERSITY OF NEBRASKA MEDICAL CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03073785
GET https://conductscience.org/api/trials/v1/NCT03073785/registered